Q4 2020 FibroGen Inc Earnings Call
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Ladies and gentlemen, thank you for standing by and welcome to the fiber churn and fourth quadrant and fully gateway the Chinese financial results Conference call. At this time all participants are useful.
Operator: Ladies and gentlemen, thank you for standing by, and welcome to the FibroGen fourth quarter and full year 2020 financial results conference call. At this time, all participants are in the listen-only mode.
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 star 1 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 our speaker today, Mr. Michael Tung. Thank you. Please go ahead. Thank you, Lyndon. Good afternoon, everyone.
And the speaker suppression of the presentation, there will be a question and answer session to ask the question. During the session you will need to press star one on the telephone please be advised that the conference is being recorded.
And require any further assistance please press star zero.
I would now like to hand, the conference of the theory Speaker today, Mr. Michael Kim. Thank you. Please go ahead.
Thank you Linda and good afternoon, everyone I'm, Michael Tung, Vice President of corporate strategy and Investor Relations of five region.
Michael Tung: I'm Michael Tung, Vice President of Corporate Strategy and Investor Relations at FibroGen. Joining me on today's call are Enrique Conterno, our Chief Executive Officer; Dr. Percy Carter, our Chief Scientific Officer; Pat Cotroneo, our Chief Financial Officer; and Dr. Mark Eisner, our Chief Medical Officer. Thane Wettig, our Chief Commercial Officer, Chris Chung, our Senior Vice President of China Operations, and Dr. Elias Khashoggi, our Senior Vice President of Clinical Development, Drug Safety, and Pharmacovigilance. The format for today's call includes prepared remarks from Enrique and Pat, after which we will open up the call for Q&A.
Joining me on today's call are Enrique Conterno, our Chief Executive Officer, Dr per seat Carter, our Chief Scientific Officer, Pat Cotroneo, Our Chief Financial Officer, Dr. Mark is and our Chief Medical Officer.
And <unk>, our Chief commercial Officer, Chris Chung, our senior Vice President of China operations, and Doctor at least the Schottky, our senior Vice President of clinical development drug safety and pharmacovigilance.
The format for today's call includes prepared remarks from and regained pet after which we will open up the call for Q&A.
Michael Tung: I'd like to remind you that remarks made on today's call include forward-looking statements about FibroGen, which may include, but are not limited to, collaborations with AstraZeneca and Astellas and financial guidance. Initiation, Enrollment, Design, Conduct, and Results of Clinical Trials Our Regulatory Strategies and Potential Regulatory Results Our Research and Development, Commercial results, and results of operations, risks related to our business, and certain other business activities. 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.
And I'd like to remind you that remarks made on today's call include forward looking statements about fibers and so statements may include but are not limited to our collaborations with Astrazeneca and astellas.
The guidance.
The initiative and initiation of enrollment design conduct and results of clinical trials of <unk>.
Regulatory strategies and potential regulatory results, our research and development activities from.
Actual results and results of operations risks related to our business.
And certain other business matters.
Each forward looking statement and is subject to risks and uncertainties that could cause actual results and events of today.
Differ materially from those projected and that statement.
Michael Tung: 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. FibroGen does not undertake any obligation to update publicly any forward-looking statements, whether as a result of new information, future events, or otherwise. The press release reporting our financial results and business update and a webcast of today's conference call can be found in the investor section of FibroGen's website at www.fibrogen.com. With that, I would like to turn the call over to Enrique Conterno, our CEO. Enrique?
The more complete description of these and other material risks can be found and fibers and <unk> filings with the SEC, including our most recent form 10-K and form 10-Q.
Garbage and does not undertake any obligation to update publicly any forward looking statements, whether as a result of new information future events or otherwise.
The press release reporting our financial results and business update and a webcast of today's conference call can be found on the investors section of Barbara just website at Www Biogen Dot com.
With that I would like to turn the call over to Enrico can turn of our CEO Enrique.
Very good.
Enrique A. Conterno: Very good. Thank you, Mike, and good afternoon, everyone. And welcome to our fourth quarter and full year 2020 earnings call. I intend to reflect on my first year as CEO of FibroGen by providing a high-level summary of important accomplishments and developments, not only in recent months but also for 2020. Pat Cotroneo, our CFO, will then review the financials, after which we will open the call for your questions.
You, Mike and good afternoon, everyone and welcome to our fourth quarter and full year, 'twenty and 'twenty earnings call.
The intent to reflect on my first year of C of O five Virgin.
By providing a high level summary of important accomplishments and developments not only in recent months, but also for 'twenty and 'twenty.
That's good for now our CFO will then review the financials after which we will open the call for your questions.
I continue to be confident and my assessment of fiber Jen has the unique opportunity to create significant value for patients and shareholders by executing on our three areas of focus.
Enrique A. Conterno: I continue to be confident in my assessment that FibroGen has a unique opportunity to create significant value for patients and shareholders by executing on our three areas of focus. Number one, ensuring regulatory and commercial success of Roxaduce, a transformational medicine for the treatment of anemia, first in patients with chronic kidney disease and with significant potential for expansion to additional indications. Number two, accelerating the development of panverlo map in three high-value indications, locally advanced and resectable pancreatic cancer, Duchenne muscular dystrophy, and idiopathic pulmonary fibrosis.
Number one and.
During regulatory and commercial success of Brooks the distance of transformational medicines for the treatment of anemia per.
And patients with chronic kidney disease and with significant potential for expansion to additional indications.
Number two accelerating the development of pump revenue might be and three high volume indications locally advanced unresectable pancreatic cancer, Duchenne muscular dystrophy, and idiopathic pulmonary fibrosis.
Enrique A. Conterno: And number three, strengthening our research capabilities to maximize our scientific and medical leadership position in both HIF and CTGF biology. In addition, we are focused on expanding our clinical development pipeline by evaluating both internal and external opportunities to address and meet medical needs. Today's call will include a review of Roxodusta, our continued strong performance in China, and our clinical trial program. Let us get started with the Roxeducet new drug application or NDA review.
And number three is.
Strengthening our research capabilities to maximize our scientific and medical leadership position in both Keith and see TGF Biology. In addition, we are focused on expanding our clinical development and pipeline by evaluating both internal and external opportunities to address unmet medical needs.
Today's call will include a review of.
The distance.
The new strong performance in China, and the clinical trial programs.
Let us get started with the rux and <unk>, new drug application of our NDA review.
Last December in the.
Enrique A. Conterno: Last December, in the final stages of review, the FDA extended the review period of the NDA by three months to review additional analysis of existing clinical data and set a new PDUFA date of March 20, 2021. And just today, we were informed by the FDA that they plan to hold an advisory committee or outcome meeting to review the NDA for Roxas Duster in the U.S. We have not received a schedule for the plan at all, and we are surprised by the timing of this request.
The final stages of review the F D. A extended the review period of the NDA by three months to review of additional analysis of existing clinical data and state of new but if a date of March 20th plenty of 21st.
Just today, we were informed by the FDA that day.
And two calls I've done Advisory committee or outcome meeting to review the NDA for the study and the U S.
We have not received the schedule for the planned outcome.
We're surprised by the timing of these requests.
Enrique A. Conterno: On three separate occasions, the FDA indicated they were not planning to hold an outcome at that time. First... when the NDA filing was accepted, then after the mid-cycle review, and finally, after the late-cycle review. However, it would not be unusual for the FDA to hold an outcome for a first-in-class new molecular entity. And, as communicated last spring, we were preparing for this possibility.
On three separate locations. The FDA indicated they were not planning to call and I'd come at the time.
First when the NDA filing was accepted the.
And then after the mid cycle review.
And finally after the late cycle review.
It would not be unusual for the FDA to haul and outcome for a first in class and new molecular entity.
And as communicated last spring we were preparing for this possibility.
We will now resume dose preparation activities and look forward to presenting the comprehensive rocks at the state data.
Enrique A. Conterno: We will now resume those preparation activities and look forward to presenting the comprehensive ROC-SEDUSTA data. We continue to have confidence in the completeness of our NDA submission and the strength of our data, and FibroGen and AstraZeneca are committed to working with the FDA to bring Roxas Dusta to patients, with an email CKD in the U.S. As you can appreciate, and as has been the case throughout the final stages of review, we will not be able to discuss the details of our FDA interaction. Our pre-commercial activities will continue as planned.
We continue to have cash.
And it's and the completeness of our NDA submission and.
And the strength of our data and.
And the fibers and and Astrazeneca are committed to working with gift the eight to bring growth of just at the patients with anemia secretly and the U S.
As you kind of appreciate and has been the case throughout the final stages of review.
We'll not be able to discuss the details of our F D a interactions.
Our pre commercial activities continued as planned.
Enrique A. Conterno: FibroGen had its largest presence ever at the American Society of Nephrology Kidney Week Conference in October of last year, and there continues to be significant interest in Roxas D'Usta from the clinical community. The momentum generated at ASN continues with additional analysis and planned disclosures of our Phase 3 data in order to maintain our HPHI scientific and clinical leadership position, and healthcare professional disease education activities are ongoing and expected to increase through the official launch.
Five region had its largest presence ever.
And the American Society of Nephrology kidney week conference in October of last year, and there continues to be significant Ainsworth and Brooks of do stuff from the clinical community.
The momentum generated at a S and continues with additional analysis and planned disclosures of the phase III data.
Order to maintain our history of Chi scientific and clinical and leadership position.
Patient.
And the health care professional and disease education activities are ongoing and expected to increase through the official launch.
Enrique A. Conterno: Our partner, AstraZeneca, has a comprehensive renal commercial presence in the U.S., and together, we're committed to making Roxas2Star available to as many CKD patients as quickly as possible. To optimize patient access, AstraZeneca is leading the discussions with both dialysis organizations and payers who cover non-dialysis patients. We have submitted a manuscript covering the phase three studies for CKD Animated Peer Review Journal. As you can see on the slide,
Our partner Astrazeneca has a comprehensive renal commercial presence and the U S and.
And together, we're committed to make because of just set available to us many sika the patients as quickly as possible to optimize speech and axis Astrazeneca is leading the discussions with both dialysis organizations and payers, who cover and non dialysis patients.
We have submitted and minus scripts.
Covering the phase III studies.
And for CK, the anemia at the peer reviewed journals.
As you can see on the slide.
Five of these minus crews have been published covering non dialysis dependent and dialysis dependent and incident dialysis data.
Enrique A. Conterno: Five of these manuscripts have been published, covering non-dialysis-dependent, dialysis-dependent, and insulin-dialysis data. Details on these publications can be found in a press release, and we expect additional publications of phase 3 data in the coming months. In Japan, our partner Astellas received additional advance approval for the treatment of anemia CKD in adult patients not on dialysis in November of 2020. In addition, in December of 2020, the 14-day prescription rule was lifted for Everest. As a result of these two events, Astellas has seen an acceleration in her brain cells' activity.
The tariffs and these publications can be found in our press release, and we expect additional publications of phase III data and the coming months.
And Japan, our partner sales received an addition of eventual approval for the treatment of anemia, and CCD and adult patients not on dialysis in November of 'twenty and 'twenty.
In addition in December of 'twenty, and 'twenty. The 14 day prescription rule was lifted before I bristle.
As a result of these two events of Astellas has seen an acceleration in the rents of uptake.
The European Medicines agency accepted the rocks the <unk> marketing authorization application for the treatment of anemia in adult patients with chronic kidney disease, both on dialysis and not on dialysis and may of 'twenty and 'twenty, we expect the decision midyear now moving.
Enrique A. Conterno: The European Medicines Agency accepted the Roxadustad marketing authorization application for the treatment of anemia in adult patients with chronic kidney disease, both on dialysis and not on dialysis, in May of 2020. We expect a decision mid-year. Now moving... Now to China.
Now to China.
We're pleased to report net sales of Brooks of boost out of $29 2 million for the fourth quarter versus $22 7 million and the third quarter the.
Total net rocks of the sales.
Sales from China for 2020, the first year because most of what's included and are in the and our D. L were $72 $5 million.
Enrique A. Conterno: We're pleased to report net sales of Roxadusta of $29.2 million for the fourth quarter versus $22.7 million in the third quarter. The total net sales of Roxadusta in China for 2020, the first year it was included in the NRDL, were $72.5 million. The continuing increase in uptake is being driven by both an expansion in hospitalists and broad adoption with enlisted hospitals. Hospital listings continue to be a key focus of our launch effort.
The continuing increase in uptick is being driven by both on expansion and hospital listings.
And broader adoption within the list at hospitals.
Of course, Peter listings continue to be a key focus of our launch efforts.
Notably.
As of the end of the year rocks and this was at least at the hospitals represented approximately 70% of the CCAR the anemia market opportunity in China.
And this is in comparison to 55 per cent at the end of the third quarter.
We're driving towards the goal of making the rocks and do something.
Enrique A. Conterno: Notably... As of the end of the year, Roksadustad was listed as a hospital representing approximately 70% of the CKD anemia market opportunity in China. This is in comparison to 55% at the end of the third quarter.
The number one and treatment option for anemia of CCAR the patients in China.
We continue to see significant blocks of do still utilization across a range of anemia of secret of the patient populations.
Approximately 60% of patients treated with drugs that do a study and China are on dialysis.
Enrique A. Conterno: We're driving towards our goal of making RoxasDustin the number one treatment option for anemia CKD patients. We continue to see significant Roxodusta utilization across a range of anemia in the CKD patient population. Approximately 60% of patients treated with Ruxodustin in China are on dialysis, split between hemodialysis and peritoneal dialysis.
Split between him of dialysis and theories of needle dialysis.
We think the hemodialysis initial adoption has been and patients who do not respond well to ECS as well as in the incident dialysis patients.
The remaining 40% of Brooks the dose the three the patients are seeking the anemia patients not on dialysis.
This broad utilization powder and bodes well for long term success and provides critical learnings as we prepare to launch rocks and the study in the U S and and other countries.
Enrique A. Conterno: Within hemodialysis, initial adoption has been in patients who do not respond well to ESAS as well as in instant dialysis patients. The remaining 40% of ROXADUSTA-treated patients are CKD anemia patients, not on the list. This broad utilization pattern bodes well for long-term success and provides critical learnings as we prepare to launch Roxadustat in the U.S. and in other countries. We look forward to keeping you updated as we advance our long-term goal of making Roxadustin the standard of care in treating China's CKD anemia.
Look forward to keeping you updated as we advance our long term goal of making and Brooks of boosted the standard of care and treating China's <unk> and MF patients.
Moving now to our clinical development.
And our third quarter earnings call, we provided the timeline guidance for most of our clinical trials.
We are reiterating that guidance today.
And do not intend to update this guidance on a quarterly basis, but he spent only where we have meaningful changes.
Starting with rux of boost it.
We recently completed enrollment and Whitney our phase II trial in patients with the chemotherapy induced anemia and top line data is expected in the second half of this year.
Enrique A. Conterno: Moving now to our clinical development. On our third quarter earnings call, we provided timeline guidance for most of our clinical trials. We are reiterating that guidance today, and do not intend to update this guidance on a quarterly basis, but it's only when we have meaningful change, starting with RoxaDust. We recently completed enrollment in... are Phase II trials in patients with chemotherapy-induced anemia, and top-line data is expected in the second half of this year.
At the conclusion of this trial is successful we plan to initiate the phase III program in collaboration with Astrazeneca and Astellas.
Matterhorn, our phase III trial, and patients with anemia of mail of Dysplastic syndrome sort of M. D. S continues to enroll with top line data expected in the first half of 'twenty and 'twenty two.
Finally, we recently completed enrollment of Aspen and the knowledge of our two phase III studies of Brooks of do studying CK the anemia with the large dialysis organizations in the United States.
Enrique A. Conterno: Upon conclusion of this trial, we plan to initiate a phase 3 program in collaboration with AstraZeneca and Astellar. Matterhorn, our phase 3 trial in patients with anemia of myelodysplastic syndrome, or MDS, continues to enroll, with top-line data expected in the first half of 2022. Finally, we recently completed enrollment in Aspen and Denali, two phase 3b studies of Roxodusta in CKD anemia with large dialysis organizations in the United States. Moving now to Panbrevlo, Mexico, for locally advanced and resectable pancreatic cancer.
Moving now to Pan bread roadmap.
And locally advanced Unresectable pancreatic cancer.
Our LAPIS phase III trial is enrolling well with top line resection data expected in the second half of 'twenty to 'twenty two.
Moving to the Shane muscular dystrophy enrollment continues in our Atlantis phase III trial and non ambulatory patients.
With top line data also expect the in the second half of 2022.
Finally in idiopathic pulmonary fibrosis, we recently initiated the first two phase III trial in December.
IPF patients have severely compromised lung function and the current COVID-19 situation continues to be extremely challenging for enrolment and both are pretty well to trial zephyrus and suffers too.
Enrique A. Conterno: Our LAPIS Phase 3 trial is enrolling well, with top-line resection data expected in the second half of 2022. Moving to Duchenne, muscular dystrophy, and Romy, progress continues in our Lelantus Phase III trial in non-ambulatory patients, with top-line data also expected in the second half of 2020. Finally, in idiopathic pulmonary fibrosis. We recently initiated our Cephris 2 phase 3 trial in December. IPF patients have severely compromised lung function.
Despite the circumstances, we have activators of significant number of additional clinical trial sites and expanding geographically, including in China.
Such that when Colombia, and Peru, which would be and are positioned to accelerate in Guam and in both trials expeditiously.
Given the different COVID-19 scenarios.
There is variability and our projected IPF timelines and will provide you with an update of the appropriate time.
Accelerant and enrollment of all of our ongoing clinical trials of while ensuring patient safety continues to be a top priority.
Enrique A. Conterno: And the current COVID situation continues to be extremely challenging. For enrollment, both are privileged to trial SEPHIRS and SEPHIRS II. Despite these circumstances, we have activated a significant number of additional clinical trial sites and expanded geographically, including in China, such that when COVID improves, we should be in a position to accelerate involvement in both trials and expeditions. Given the different COVID scenarios, there is variability in our projected IPF timelines, and we'll provide you with an update at the appropriate time.
Now, let me touch briefly on the application of our pioneering expertise.
And hypoxia inducible factor of case.
Two of them, so glitter rates and symbology.
And connective tissue growth factor or see TGF biology and <unk>.
Order to advance innovative medicines for the treatment of anemia of fibrotic disease and cancer.
And 2020.
We completed a thorough internal review of all of our programs and.
And we plan to continue advancing and <unk>.
And the molecules in the development pipeline.
In addition, we are seeking to access external innovation.
Finally, it is my pleasure to address another important accomplishments of the hiring of a significant leadership talent.
Enrique A. Conterno: Accelerating enrollment of all of our ongoing clinical trials while ensuring patient safety continues to be a top priority. Now, let me touch briefly on the application of our pioneering expertise in hypoxia, inducible factor, or HIF, to Oxoglutarate and Simology, and Connective Tissue Growth Factor, or CTGF, biology, in order to advance innovative medicines for the treatment of anemia, fibrotic disease, and cancer.
Which includes the appointments of ducts of Percy Carter Chief Scientific Officer.
The remark Eisner of Chief Medical Officer, and Saint <unk>, as Chief commercial officer and <unk>.
Summary, 'twenty and 'twenty, what's the productive transition of the ear and look forward to more progress and good set of goals in 'twenty and 'twenty one.
And I will now turn the call over to our CFO. That's good for now for the financial update Pat.
Thank you Enrique as announced today total revenue for the fourth quarter of 2020 was $65 million as compared to $8 million for the fourth quarter of 2019.
Enrique A. Conterno: 2020. We completed a thorough internal review of all of our programs, and we plan to continue advancing internal molecules in our development pipeline. In addition... We are seeking to access external innovation. Finally, it is my pleasure to address another important accomplice: The Hiring of Significant Leadership Talent, which includes the appointments of Dr. Percy Carter, Chief Scientific Officer; Dr. Mark Eisner, Chief Medical Officer; and Thane Wettig, Chief Commercial Officer.
The current quarter revenue consists of net product revenues of $29 $2 million for rocks of do start sales in China.
The one $5 million and development revenue.
And $14 $3 million and license revenue related to any day approval in Japan.
For the same period operating costs and expenses were $123 million and net loss was $58 $6 million or 64 cents per basic and diluted share as compared to operating costs and expenses of $108 $4 million and the net loss.
Enrique A. Conterno: In summary, 2020 was a productive transitional year, and I look forward to more progress against our stated goals in 2021. I will now turn the call over to our CFO, Pat Cotroneo, for the financial update.
Loss of $98 $1 million or $1 12 per basic and diluted share for the fourth quarter last year.
Included in the operating cost and expenses for the quarter ended December 31, 2020 was and aggregate noncash portion totaling $26 $9 million.
Pat Cotroneo: Thank you, Enrique. As announced today, total revenue for the fourth quarter of 2020 was $65 million, as compared to $8 million for the fourth quarter of 2019. The current quarter revenue consists of net product revenues of $29.2 million for Roxadustat sales in China, $21.5 million in development revenue, and $14.3 million in license revenue related to NDD approval in June. For the same period, operating costs and expenses were $123 million, and that loss was $58.6 million, or 64 cents per basic and diluted share, as compared to operating costs and expenses of $108.4 million and a net loss of $98.1 million, or $1.12 per basic and diluted share, for the fourth quarter last year.
Of which $23 million was the result of stock based compensation expense as.
As compared to an aggregate noncash portion of $22 $1 million of which $17 $4 million was the result of stock based compensation expense for the same period and the prior year.
At December 31, five region had $732 $1 billion and cash cash equivalents restricted time deposits investments and receivables.
At this time I would like to outline some changes and financial reporting starting next quarter that result from the Amendment tour of China agreement with Astrazeneca.
As we have previously reported the amendment and is expected to result in earlier and more consistent profitability to five region based on the continued 50 50 profit share with Astrazeneca.
Pat Cotroneo: Included in operating costs and expenses for the quarter ended December 31, 2020, was an aggregate non-cash portion totaling $26.9 million, of which $20.3 million was a result of stock-based compensation expense, as compared to an aggregate non-cash portion of $22.1 million, of which $17.4 million was a result of stock-based compensation expense for the same period in the prior year. At December 31, FibroGen had $732.1 million in cash, cash equivalents, restricted time deposits, investments, and receivables.
Under the amendment, we have formed a jointly owned distribution entity. The J D. E that began operations in Q1 2021.
The JV will be responsible for selling walks of do stat to distributors.
And we will pay for Astrazeneca has commercialization efforts in China, and Az's portion of profit share.
Previously fibre channel was responsible for these items.
The JV is expected to account for over 95% of overall, China rocks and do staff sales volume going forward.
While the rest will continue to be conducted directly by fibre channel.
Pat Cotroneo: At this time, I would like to outline some changes in financial reporting starting next quarter that result from the amendment to our China Agreement with AstraZeneca. As we have previously reported, the amendment is expected to result in earlier and more consistent profitability for FibroGen based on a continued 50-50 profit share with AstraZeneca. Under the amendment, we have formed a jointly owned distribution entity, the JDE, that began operations in Q1 2021. The JDE will be responsible for selling Roxaduce fat to distributors and will pay for AstraZeneca's commercialization efforts in China and AZ's portion of the profit share. Previously, FibroGen was responsible for these items.
Starting in Q1, 'twenty 'twenty, one fibrogenesis revenue will be based on sales to the J D E and a transfer price as well as fiber regions direct sales the.
The transfer price is expected to be and the range of 30% to 45%.
Of J D E and net sales, which reflects the J D E pain, both astrazeneca and commercialization expenses.
And the Astrazeneca is portion of the profit share.
In addition to continued to provide context for the operating results of our lots of <unk> business in China. We also plan to share. The overall net sales of rocks and do staff I E. The combination of and sales by Astrazeneca and and sales by fiber Jen.
Pat Cotroneo: The JDE is expected to account for over 95% of overall China Roxadustat sales volume going forward, while the rest will continue to be conducted directly by FibroGen. Starting in Q1 2021, FibroGen's revenue will be based on sales to the JDE at a transfer price, as well as its direct sale. The transfer price is expected to be in the range of 30 to 45 percent of J.D.E. net sales, which reflects the J.D.E.
Looking ahead at our broader financial picture, we have a total of $245 million of potential milestones expected. This year for anticipated and U S and EU approvals and first commercial sale and the U S.
At this point and time, we have no changes and expectations and any of the anticipated milestones between now and the end of the year.
Based on our latest forecast data, we estimate our 2021 ending balance of cash cash equivalents restricted time deposits investments and receivables to be and the range of $660 million to $670 million.
Pat Cotroneo: Paying both AstraZeneca's commercialization expenses and AstraZeneca's portion of the profit share. In addition, to continue to provide context for the operating results of our Roxadustat business in China, we also plan to share the overall net sales of Roxadustat, i.e., the combination of end sales by AstraZeneca and end sales by FibroGen. Looking ahead at our broader financial picture, we have a total of $245 million in potential milestones expected this year for anticipated U.S. and EU approvals and first commercial sale in the U.S. At this point in time, we have no changes in expectations for any of the anticipated milestones between now and the end of the year.
Assuming U S and EU approval in 2021.
Thank you and I would now like to turn the call back over to Enrique.
Yeah.
In closing this is an important time for fiber Gen Brooks.
Brooks of do such has launched in China, Japan, and other east under regulatory review in the U S Europe and other geographies.
And revenue might be as a wholly owned and potential first in class of new medicine and <unk>.
Phase III development and the three high value indications of locally advanced Unresectable pancreatic cancer, and Duchenne muscular dystrophy and idiopathic pulmonary fibrosis.
We are reenergizing, the research agenda to deliver and R&R unique scientific expertise in parallel we're building world class research capabilities internally, while also looking externally for opportunities with the goal of expanding our pipeline of innovative drug candidates.
Pat Cotroneo: Based on our latest forecast data, we estimate our 2021 ending balance of cash, cash equivalents, restricted time deposits, investments, and receivables to be in the range of $660 to $670 million, assuming U.S. and EU approval in 2021.
We have strengthened our leadership team, which will be instrumental for our strategic growth.
We are in a strong financial position.
Brooks.
Sales from ramp up with approximately $732 million and cash and.
Enrique A. Conterno: Thank you, and I would now like to turn the call back over to Enrique. In closing, this is an important time for FibroGen. Roxadustat has been launched in China and Japan and is under regulatory review in the U.S., Europe, and other geographies.
And another 245 million and anticipated and the Brooks of do some milestone payments expected during 'twenty and 'twenty one.
Going forward I.
And I believe we're clearly positioned for success now I would like to turn the call back to the operator for questions.
Enrique A. Conterno: Pambrellu Mavisa-Holy on potential first-in-class numeracy. Phase III studies are developing in the three high-value indications of locally advanced and resectable pancreatic cancer, Duchenne muscular dystrophy, and idiopathic pulmonary fibrosis. We are re-energizing our research agenda to deliver on our unique scientific expertise. In parallel, we're building world-class research capabilities internally, while also looking externally for opportunities, with the goal of expanding our pipeline of innovative drug candidates. We have strengthened our leadership team, which will be instrumental in our strategic growth. We are in a strong financial position as RoxaDusta sales ramp up, with approximately $732 million in cash and another $245 million in anticipated RoxaDusta milestone payments expected during 2021.
As a reminder to ask the question you want me to.
Taiwan on your telephone Covid.
The judge our question and perhaps to caliber hedge gain.
Again, ladies and gentlemen, if you had the question at this time please spread the time and then the number one key on your telephone.
Your first question comes from Joel Beatty from Citi. Your line is open.
Hi, Thanks for taking the questions. The first one is are you able to share anything about the capex that you are preparing to address at the AD com.
Thank you Joe let me provide just a brief.
The answer I'm going to high scores from Mark Eisner to comment, but I'm clearly.
At this point and that we're not and are positioned to provide them.
And updates on that as you know there's typically a report that the FDA will basically make public prior to the outcome of this only a few days before the outcome is actually held and we don't have a set date for the outcome of the states and we do not provide too.
Operator: Looking forward, I believe we're clearly positioned for success. Now, I would like to turn the call back to the operator for, As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound or hash.
The comment on our regulatory interactions with the FDA, Mark I'm I'm going to ask Mark I sort of if you kind of see any additional comments.
Operator: Again, ladies and gentlemen, if you have a question at this time, please press the star and then the number one key on your telephone. Your first question comes from Joel Beattie from Connecticut. Your line is open.
Yes, no and thanks for the question as you know the FDA uses advisory committees to bring in external scientific clinical or other perspectives and tourists review and it would not be unusual to have and I comscore first in class new molecular entity and this case of what's surprising is the timing as Enrique had alluded.
Enrique A. Conterno: Hi, thanks for taking the questions. The first one is, are you able to share anything about the topics that you're preparing to address at the EdCom? Thank you, Joe.
Two and his introductory comments at this point, we're going to resume our preparation activities for the Advisory Committee and we'll look forward to presenting the comprehensive rocks and do stock program and its data we continue to have confidence and the completeness of our NDA submission and the strength of our data and along with our partner Astrazeneca where committee.
Enrique A. Conterno: Let me provide just a brief answer. I'm also going to ask Mark Eisner to comment, but clearly, at this point in time, we're not in a position to provide an update on that. As you know, there's typically a report that the FDA will basically make public prior to the outcome, which is only a few days before the outcome is actually held.
To working together with the FDA to bring rocks and do start the patients with anemia of CK day in the U S.
Thanks again for the question.
Thanks, and then maybe one follow up to the can you share anything about how you and astrazeneca collaborate for the AD com preparations and if there is one company and taking the lead.
Mark Eisner: We don't have a set date for the outcome at this stage, and we do not have any comment to make on a regulatory interaction with the FDA. Mark, I'm going to ask Mark Eisner if he has any additional comments. Yeah, and thanks for the question. As you know, the FDA uses advisory committees to bring in external scientific, clinical, or other perspectives into its review, and it would not be unusual to have an adcom for a first-in-class new molecular entity. In this case, what's surprising is the timing, as Enrique had alluded to in his introductory comments.
Yeah. This is really age.
And being a joint effort the joint process.
And clearly Astrazeneca has considerable expertise when it comes to outcomes and we need to make sure that that is.
Being fully leveraged but I think the when we were preparing a buck in the spring that wasn't the case very collaborative and I expect that it will continue to be very much of joined the firm.
Mark Eisner: At this point, we're going to resume our preparation activities for the advisory committee, and we'll look forward to presenting the comprehensive Roxodusta program and its data. We continue to have confidence in the completeness of our NDA submission, the strength of our data, and, along with our partner AstraZeneca, we're committed to working together with the FDA to bring Roxodusta to patients with anemia of CKD in the U So, thanks again for the question.
Great. Thank you very much.
Your next question comes from Michael Yee from Jefferies. Your line is open.
Hi, guys. Thanks.
Two questions for you guys.
You can understand that people are I guess confused and a bit perplexed by the timing and and also just the chronology of how things are played out. So the first question is just.
And maybe Enrique can you just give us some comfort such that the discussions here or the debates or the issues here of more of a labeling and black box safety scenario question.
Enrique A. Conterno: One follow-up to that. Can you share anything about how you and AstraZeneca collaborate on the ad cam preparations and if there's one company taking the lead? This has been a joint effort, a joint process.
Such that whatever happens here you don't hit the peak sales are likely to change too much and you've kind of made the comment before but maybe.
Maybe you could comfort us in some way and the second question is more of a logistical question for the team I think that.
Enrique A. Conterno: Clearly, AstraZeneca has considerable expertise when it comes to outcomes, and we need to make sure that that is being fully leveraged. But I think when we were preparing back in the spring, that was the case; very collaborative. I expect that it will continue to be very much a joint effort. Great, thank you very much.
You can't really have two formal could you fix extensions. If you go look of documents. So do you just expect that we're going to pass the producer date have to deal with an AD com and now we're just kind of go from there or do you expect the redo frigid would actually be forming of change. So we could have some visibility on things. Thank you.
Michael Jonathan Yee: Your next question comes from Michael Yee from Jefferies. Your line is open. Hi guys, thanks. Two questions for you guys. You can understand that people are, I guess, confused and a bit perplexed by the timing and also just the chronology of how things are playing out.
Yeah. Thank you for your question and Michael Clearly I think and let me try to address maybe the first part the the.
And the last part of your question.
Our understanding is the the produce they'd can be extended once that extension happened. So at this point and time, we expect that the.
Enrique A. Conterno: So the first question is just, maybe Enrique, can you just give us some comfort such that the discussions here or the debates or the issues here are more of a labeling and black box safety scenario question? you know, such that whatever happens here, you don't believe that peak sales are likely to change too much. You've kind of made that comment before, but you know, maybe you could comfort us in some way.
The data will be missed and therefore and.
And we will have the outcome of.
And some point in time, but the with no longer basically and active.
And to do for the date I think of your next and Europe Europe.
Sure.
Sure. The first part of your question was related to them being bought more and more specific on the nature of the outcome clearly.
Enrique A. Conterno: The second question is more of a logistical question for the team. I think that you can't really have two formal PDUFA extensions if you go look at the documents. So do you just expect that we're going to pass the PDUFA date, have to deal with an advertiser, and then we just kind of go from there? Or do you expect that PDUFAs would actually be formally changed so we would have some visibility on things?
And when it comes to outcomes of outcomes are looking at the overall benefit risk profile of the product of course, and they tried to get.
And.
The external scientific expertise to bear.
I'm not in a position to be able to comment on.
The nature of that and I think we have to prepare for it and.
And I, we want to see of course Wendy's outcome will be scheduled we don't have a set date for it at this time keep in mind that we were notified of this today.
Enrique A. Conterno: Thank you. Yeah, thank you for your question, Michael. Clearly, I think, let me try to address maybe the first part, the last part of your question. Our understanding is that the PDUFA date can be extended once.
Well okay.
Thank you.
Your next question comes from Edwin Zhang from H C. Wainwright Your line is open.
Yeah.
Enrique A. Conterno: That extension happens at this point in time, we expect that the PDUFA date will be missed, and therefore, we will have the outcome at some point in time, but with no longer basically an active PDUFA date. I think the first part of your question was related to being more specific on the nature of the outcome, clearly. When it comes to outcomes, outcomes are looking at the overall benefit-risk profile of the product, of course. They try to get...
Hi, Thanks for taking my questions first one how much do think the AD com decision related to the new analysis, you submitted to the FDA two months ago and.
And second just falloff and all of the Purdue.
Just to clarify are you going to get the new producer of data from the FDA or not and.
And I'll be going to know the and you do about it.
Best of luck. Thank you.
Yeah.
Yeah, we don't believe there would be of new producer date, and given that there was sort of radio and extension.
Enrique A. Conterno: External Scientific Expertise. Thank you for joining us. The nature of that, and I think we have to prepare for it, and we want to see, of course, when this outcome will be scheduled. We don't have a set date for it. Keep in mind that we were notified of this today. Whoa, okay.
And I I am sorry, I missed the first part of your question.
So how much do you think the.
And com decision from the FDA.
Is it related to the new analysis, you submitted to the FDA two months ago.
And we don't want to speculate.
Okay, maybe one more.
Operator: Thank you. Your next question comes from Edwin Zhang from H.C. Wainwright, Utah. Hi.
Does this regulatory agencies and change your expectation of a clean or.
Edwin Zhang: Thanks for taking my questions. First one, how much do you think this Adcom decision is related to the new analysis you submitted to the FDA two months ago? And second, to follow up on the PDUFA date, just to clarify, are you going to get a new PDUFA date from the FDA or not? And when are we going to know the new PDUFA date? if they ask why.
Or differentiated label of compare to yesterday.
Yeah listen I think at this point in time, we have to go through the outcome, we have product with the significant amount of clinical data keep in mind that our people at the data for the U S, including over 8000 patients and we've discussed of the clinical data.
Enrique A. Conterno: Yeah, we don't believe there will be a new PDUFA date, given that there was already an extension. And I am sorry, I missed the first part of your question. So how much do you think this Adcom decision from the FDA is related to the new analysis you submitted to the FDA two months ago? We don't want to speculate. Okay, maybe one more.
Hum at length, we continue to stand behind our data and the strength of the of the day that some of the data and now has been published there are five primary minus scripts that have been published and a number of more than half of our upcoming but at this point and time I don't want to speculate on the nature of the outcome.
We very much look forward to two.
Enrique A. Conterno: Does this regulatory decision change your expectation of a clean or differentiated label compared to ESAs? Yeah, listen. I think at this point in time, we have to go through the outcome. We have a product with a significant amount of clinical data. Keep in mind there are people to data for the U.S., which included over 8000 patients. We discussed the clinical data. At length, we continue to stand behind our data and the strength of the data. Some of the data has now been published. There are five primary manuscripts that have been published and a number of more that are upcoming.
Have the opportunity to share the rocks and just the data and in <unk>.
Police force.
Great. Good luck on the outcome. Thank you.
Yeah.
Your next question comes from Geoffrey Porges from SBB and giving your line is open.
Thank you.
The number of questions related to this topic.
First the retail.
And youre answering a lot of these regulatory questions. It would be helpful with the.
The.
Official regulatory representative fibers and could answer the questions but.
And this amount to a complete response letter to your application.
And particularly given the amount of time, it's kind of required to prepare our full company package and the Fda's package and it would seem so just kind of be much more than 30 days.
Enrique A. Conterno: But at this point in time, I don't want to speculate on the nature of the outcome. We very much look forward to having the opportunity to share the Rochester data in a public forum.
After the prior produced per day.
And secondly, it's kind of certainly the hub.
Operator: Good luck on the EPCOM. Thank you. Your next question comes from Jeffrey Portgies from SBB Living. Your line is open.
For us and the investors to be confident.
And Youre approval since.
As far as we know you've replaced most people and the organization who are familiar with the very extensive amount of clinical data.
Jeffrey Portgies: Yes, thank you. A number of questions related to this topic. First, Enrique, you're answering a lot of these regulatory questions. It would be helpful if the official regulatory representative for FibroGen could answer the questions. But why doesn't this amount to a complete response letter to your application?
And then lastly could you confirm whether this.
Review all of the.
Whatever the outcome is kind of be will it be held.
The hematology.
Division or the cardio renal division and will it be examining and hearing the objections from the citizens petitions. Thank you.
Enrique A. Conterno: And particularly given the amount of time it's going to require to prepare a full company package and the FDA's package, it would seem certain that it's going to be much more than 30 days after the prior PDUFA date. Secondly, it's going to certainly be hard for us and investors to be confident in your approvals. As far as we know, you've replaced most people in the organization who are familiar with the very extensive amount of clinical data.
Yeah.
So let me let me try to address some of your question someone else. So I'll ask Mark Eisner too maybe.
And maybe make some comments that he and she has far more she is the chief Medical Officer also has.
The BRIC a regulatory responsibilities.
First of these the virtual meeting we believe is going to be the cardio renal Advisory Committee.
So that's that's that's how we understand.
Enrique A. Conterno: And then lastly, could you confirm whether this review or whatever the outcome is going to be, will it be held by the hematology division or the cardiorenal division and will it be examining and hearing the objections from the citizen's petitions? Thank you. But let me try to address some of your questions. I'm also going to ask Mark Eisner to maybe make some comments. He has formal regulatory responsibility as the chief medical officer.
And I understand and based on the communication with.
And with the FDA, which happened today.
We are I think that you are making reference to.
The only use retirement and chief.
Medical offices and keep in mind, the purely still an employee of fiber Gen. At the stage and she also has a and agreements and consulting agreement over the next six months plus for employment.
Enrique A. Conterno: First, this, the advisory committee we believe is going to be the Cardio Reno Advisory Committee. So that's how we understand it based on the communication with.., with the FDA, which happened today. I think you are making reference to Peony Yu's retirement as chief medical officer.
Here at the five of them to continue to provide advice.
I feel that the strength of our team is considerable when it comes to Brooks of dust of data and not just here of the Firebird and but also a sort of Senegal I meant and then I'm going to ask Mark Eisner two of US will provide some additional comments or ought to what I'm sharing.
Enrique A. Conterno: Keep in mind that Peony is still an employee of FibroGen at this stage, and she also has an agreement, a consulting agreement over the next six months post her employment here at FibroGen to continue to provide advice. I feel that the strength of our team is considerable when it comes to Roxas-Dustin data, not just here at FibroGen but also at AstraZeneca. And then I'm going to ask Mark Eisner to also provide some additional comments or add to what I'm sharing. Yeah, thanks, Enrique. So, the FDA did not issue a complete response letter.
Okay, yes, thanks, Enrique so the FDA did not.
Issue of complete response letter of complete response letter would indicate that the FDA had completed its review of the FDA review of our NDA is continuing and ongoing and the FDA wants to have an advisory committee in order to bring external expertise clinical and scientific and otherwise.
And to the review so that they can complete their review. So you know, it's a very different scenario to get and advisory committee of compared to the complete response letter I mean to address the specifics of your timing yes.
Mark Eisner: A complete response letter would indicate that the FDA had completed its review. However, the FDA review of our NDA is continuing and ongoing, and the FDA wants to have an advisory committee in order to bring external expertise, clinical, scientific, and otherwise, into the review so that they can complete their review. So, you know, it's a very different scenario to get an advisory committee compared to a complete response letter. I mean, to address the specifics of your timing, yes, it's a little late in the game in the review process to get a request for an advisory committee, but the FDA is well within its rights and regulations to request an advisory committee at any time, and we're very willing and able to have this discussion in public and Mark, sorry, was this a change in the reviewing division, though, from the HAM to the CardioRAM? There was no change in the reviewing division, no.
It's a little late in the game and the review process to get a request for an advisory committee, but the FDA is well within its rights and regulations to request, an advisory committee and anytime and we're we're very.
Willing enable to have this discussion and public and present, our data, which as we alluded to before we're quite confident of them Mark.
So with this the change and the reviewing division the from the Haim two of cardio renal.
There was no change in the reviewing division now.
Okay. Thank you.
Your next question comes from Annabel <unk> from Stifel. Your line is open.
Hi, Thanks for taking my question and I promise I won't ask about the outcome because it doesn't seem like you can answer many of them, but maybe we can talk about.
Some of the signals that you're getting ex U S. Obviously.
Sales in China, and going well of the mix of.
Mark Eisner: Okay, thank you. Your next question comes from Ennabel Samimy from Stifo. Your line is open.
Sales day.
The non dialysis isn't proofing, Japan was improved and non dialysis and the French issue of temporary authorization with true.
Annabel Eva Samimy: Hi, thanks for taking my question. I promise I won't ask about the adcom because it doesn't seem that you can answer many of them, but maybe we can talk about some of the signals that you're getting at CUS. Obviously, sales in China are going well, dialysis to non-dialysis is improving, and Japan was approved for non-dialysis. Even the French issued temporary authorization with treatment up to 12 grants for desolators.
Of the trough.
That's the deciliter of how should we read the signals abroad, and how can that help you.
And frankly help you with the SBA and.
And there's this process along can you draw from all of that information and generated globally and given some.
Some of the moves and that we're seeing and China are you still assuming.
Our $500 million opportunity in China or is that and moving target. Thanks.
Enrique A. Conterno: So how should we read these signals abroad and how can that help you and, frankly, help you with the FDA to move this process along? Can you draw from all of that information that's being generated globally? And given some of the movement that we're seeing in China, are you still assuming a 500 million opportunity in China, or is that a moving target thing? Yeah, no. I think what we said is that, and we're very excited, by the way, with the way our Chinese business continues to progress. We have stated that we view the opportunity in China for Roxaduza to be able to reach peak sales north of half a billion dollars.
Yeah, No I think what we said is that.
And we're very excited by the way with the way our China.
Business continues to progress we have stated that we view the opportunity in China to be able to reach forks of do set to be with the reach peak sales north of half a billion dollars. It is pretty clear that the launch continues.
The go very well and we expect continued growth in China as we look at 'twenty and 'twenty, one and so we're very excited about the we are indeed, the we will of course conduct the pharmacovigilance activities in both China, and Japan, where the product is launched and we as you mentioned we need to make these also matter.
Enrique A. Conterno: It is pretty clear that the launch continues to go very well, and we expect continued growth in China as we look at 2021. So we're very excited about that. We are indeed, we of course conduct pharmacovigilance activities in both China and Japan where the product is launched, and we, as you mentioned, we need to make this also matter when it comes to the evidence that we basically have and how the acceptance and adoption and the utility that the patient basically has in the country where we're launching. I think this is an important factor. Operator?
And when it comes to the evidence that we basically have and how are the acceptance and adoption and the utility the the patient basically has and the countries where we're launching so I think the sudden these and import them.
The factor of course.
Right.
Okay.
Operator. Your next your next question comes from Jason The Berry from Bank of America. Your line is open.
Operator: Your next question comes from Jason Gerberry from Bank of America. Your line is open. Hey guys, thanks for taking my question. Just from a timing perspective, so as we think about potentially modeling the timing implications here. So it sounds like it's a moving target with at least a 55-day notice period. Will they let you know in terms of timing from that to an ad comms? So I would assume, at least to be safe, three to six months as a delay here.
Hey, guys. Thanks for taking my question.
Just from a timing perspective.
So as we think about potentially modeling the of the timing implications here. So it sounds like it's a moving target with at least the 55 day notice period.
And when they let you know in terms of timing from that too and outcome. So I would assume at least could be say three to six months.
Jason Matthew Gerberry: I'm not sure if you want to comment on those timing considerations. And I realize it's been a very..., short amount of time since you've had to digest this information, but any analog situations that you may have looked at or come in aware of as it pertains to a novel mechanism and anything that might give you or us some sort of comfort as it pertains to this situation in general. Thanks. Yeah, no.
As of as the delay here and I'm not sure. If you want to comment on the timing considerations and I realize it's been a very.
Short amount of time since you've had to digest the information, but any analog situations that you may have looked at or come and aware of and as it pertains to a novel mechanism and and anything that that might give you of our us.
I'm sort of.
Comfort as it pertains to this situation and general thanks.
Yeah, no. Thank you very much and we are quite frankly and unprecedented territory. When it comes to having had an extension and then within the sanction period now.
Enrique A. Conterno: Thank you very much. We are, quite frankly, in unprecedented territory when it comes to having had an extension and then, within the extension period now, having... you know, and Atcom. Clearly, um, uh, not, um... Not a good situation from a timing perspective. We don't question the...
Having.
On the <unk>.
Outcome.
And clearly I'm not I'm.
Not a good situation from a timing perspective, we don't question then the.
And the possibility or the the wisdom of having of not come in fact, the we had him very.
Enrique A. Conterno: The possibility or the wisdom of having an outcome. In fact, we had very much shared that we were preparing for that back in the spring, but an outcome was not decided. So now we find ourselves very late in the process. At this point in time, we have to look forward to trying to prepare in the best way possible to ensure that we can have..., and sharing all of our data and why we have confidence. So we will be looking, of course, at other types of examples and so forth and learning from that as part of the outcome preparation. I don't know, Mark Eisner, if you want to add anything. No, I think you summarized it well, Enrique.
Very much share that we were preparing for that back in the spring but.
At and.
And I come with not the calls so now we find ourselves very late in the process and at this point and time, we have to look forward to try to prepare and the best way possible to ensure the week and have the most successful outcome possible.
And sharing of all of our data and why we have the confidence that we have on Brooks of do stuff. So am I are we will be looking of course at.
And other types of examples and so forth and learning from the this part of the outcome of preparation.
And I don't know and Marc I'm wondering if you want to add anything to what I said.
Yeah.
No I think you're somewhere and say well Enrique I mean, we don't know the date of the outcome yet so it's difficult to speculate on the exact timeframe, but we'll be preparing a carefully and we'll be ready for the discussion and we actually welcome the.
Mark Eisner: I mean, we don't know the date of the ag comm yet, so it's difficult to speculate on the exact timeframe, but we'll be preparing carefully. We'll be ready for the discussion. And we actually welcome the input from nephrologists and the external medical and scientific community. Just the timing was surprising.
Input from Nephrologists and the external medical and scientific community just the timing is a was surprising.
Sure Okay understood.
Operator: Sure. Okay. Understood. Thanks so much.
Thanks, so much.
Your next question comes from Yaron Werber from Cowen Your line is open.
Yaron Werber: Your next question comes from Yaron Verber from Cobham. Your line is open. Yeah, hey, thanks for taking my question. So, Enrique, I just have maybe a couple of questions.
Yeah, Hey, thanks for taking my question so.
So and we kind of just maybe a couple of questions number one I was under the impression that the original NDA was sent the hematology. So is it the hematology and cardio renal for advice and the cardio renal and comm was called just the week it sounds like the they didn't send the application across the of different division, but it sounds like they're calling.
Enrique A. Conterno: Number one, I was under the impression that the original NDA was sent to hematology, so is it that hematology asked CardioRenal for advice, and the CardioRenal Adcom was called just so we know, it sounds like they didn't send the application across to a different division, but it sounds like they're calling an Adcom from another division, and not totally surprising given that that division has experience at least with ESAs And then secondly, as you think about OPEX and for this year, and I know you don't give guidance, but can you give us a little bit of a sense of what's going on with IPF, which is a little slow because of COVID, but just a little bit. What do we think about OPEX? Thank you. Yeah, so your understanding is also the understanding that I had on both hematology and renal; they are both under the same overall leadership at the FDA.
And the outcome from another division and not totally surprising given that the vision is experienced at least with the ESA and then secondly, as you think about Opex and for this year and I know you don't give guidance, but can you give us a little bit of a sense, what's going on with <unk>.
ICF is a little slow because of COVID-19, but just a little bit of how do we think about opex. Thank you.
Yeah. So yeah, you're your understanding of the social and the understanding that I had on both the hematology and renal and they're both under the over at the same overall leadership.
F D a.
But we were informed today that and.
Enrique A. Conterno: But we were informed today that Cardio Reno would be the one basically conducting the outcome or hosting the outcome. Sorry, I missed your, the second part of your question was related to COVID. Were you asking about operating expenses? Exactly. Some of the R&D would have been IPF-related, but that's slower to ramp up.
And that cardio.
Cardio renal would be the one basically conducting the the outcome or calling on course and the outcome sorry I missed your the second part of your question was related to Covid were you asking about operating expenses.
Exactly yeah I'm, just you know some of the R&D would've been IPF related but that's slower to ramp. So just how do we think about you know the opex for the year overall, and maybe a little bit of R&D. Thank you.
Enrique A. Conterno: So just how do we think about the OpEx for the year overall and maybe a little bit of R&D? Thank you. Yeah, we, of course, are looking at our operating expenses. We do this as a matter of discipline.
Yes.
And of course of or looking at the operating expenses. We do this as a matter of the discipline whenever we had even the three month extension.
Enrique A. Conterno: Whenever we had even the three-month extension, I asked for an overall review of our operating expenses. And given that we were going to be launching Broxadusted later, now we need to undergo a similar process now that we have a further delay. So clearly, when it comes to PAM, we're trying to enroll as quickly as we can, but we need to be thoughtful about every single expense here at FibroGen. We do have a good balance sheet and a good position, but we need to make sure that it's invested in the things that can add the most value at all times and continue to have operating discipline whenever things and some of the assumptions change.
And I ask for and overall review of operating expenses and.
And given that we were going to be launching Brooks of just the later and now we need to undergo a similar process now that we have a further delay.
And so clearly.
When it comes to bomb with trying to enroll as quickly as we kind of but we need to be thoughtful about every single expense share, it's a fiber and and we do have a good balance sheet and a good position, but we need to make sure that he's investing and the things that can add the most value at all times and continue to have the operating discipline anytime things and some of them.
Assumption change.
Great. Thank you so much.
Yeah.
Your next question comes from Andy Shay from William Blair. Your line is open.
Operator: Great, thank you so much. Your next question comes from Andy Shea from William Blair. Your line is open. Oh, great. Thanks for taking my question. So, I'm just wondering, you know, high level, heading into the Adcom, what's your confidence level, right? So basically, you know, before, it was kind of a two-party interaction between you and the FDA, the Renal Cardio Division. And now, you know, they're bringing in, you know, a third-party external expert, you know, kind of democratizing the process. So maybe comment on the confidence level and the ability for you to kind of highlight the data in that avenue. And also for the preparation.
Oh, great. Thanks for taking the question so.
And I'm just wondering high level.
And.
Heading into the AD com.
What's your confidence level right. So basically before it's kind of a true party interaction between you and the FDA the veto cardio the vision and now they are bringing in.
Third party external.
Expert.
That's kind of the market sizing of the process. So maybe comment on the the.
The confidence level.
And the ability for you to kind of highlight.
The data and that the Avenue.
And also for the preparation.
And for incident dialysis is that is kind of a separate.
Population that you would want to kind of.
Single out during the presentation.
Yeah, clearly I am I want I wont be sharing what are we planning to present and so forth, but you can imagine of course.
And the data that we have and incident dialysis. We believe is some of them some of our strongest data as we think about mace and mace plus significance.
Andrew Ko: For incidence dialysis, is that kind of a separate population that you would want to kind of single out during the presentation? Yeah, clearly, I won't be sharing what we are planning to present and so forth, but you can imagine, of course, the data that we have on insulin dialysis is some of our strongest data, as we think about MACE and MACE+, significance in that population. So clearly, very, very important data.
And that population and Ah.
So clearly very very important data I, what I would share I think of you you talked about the.
Democratizing the price of just transparency, but I think it's also a good opportunity to get the.
And the external community, including and.
Nephrologist patient advocacy to opine about.
Some of the needs are out there and I think honestly I think in that in and that the way I think this is.
Enrique A. Conterno: What I would share, I think you talked about democratizing the process, yes, transparency, but I think it's also a good opportunity to get the external community, including, [inaudible] It could be refreshing to be able to hear some of the interest that the clinical community has in the product. That's what we hear, basically, whether it's at ASN, either directly, through shared comments, but also how interested people are in the different presentations that we had, whether they were oral presentations or posters at ASN. I am, I look forward to the full engagement of, So that's the perspective that I... Okay, thank you, that's helpful.
And that the outcome could be refreshing to be able to two here.
Some of the interest of the clinical community kind of some of the product and that's what we're here basically whether it's the ASN.
Either.
Directly shared comments, but also how you how interested people are and the different presentations that we had weather where oral presentations or.
Posters at the ASN and so.
And I am I look forward to the full engagement of the scientific community. So that's the perspective that I would provide.
Okay. Thank you that's helpful.
Operator: Your next question comes from Paul Choi from Goldman Sachs. Your line is open. Hi, this is Eliza on behalf of Paul.
Your next question comes from Paul Choi from Goldman Sachs. Your line is open.
Hi, This is the Liza on for Paul Thanks for taking the question.
Paul Choi: Thanks for taking the question. A quick one on the Adcom for us. It seems that previously the FDA was reviewing Groxa in terms of both the DD and NDD populations together.
One on the outcome for us it seems that previously the FDA was reviewing graph. The in terms of both of the D D and N D day populations together.
Operator: With the new news on the Adcom, are you guys still expecting a similar review? Do you have any indication that the agency might review these populations and or indications more separately? How you're thinking about that would be great.
With the new news on the item or are you guys still expecting a similar revenue do you have the any indication that the agency might review the population and.
There are indications of our separately and how youre thinking about that would be great. Thank you.
Enrique A. Conterno: Thank you. Yeah, I will have Mark Eisner maybe comment on and respond to that question. Yeah, so it's a great question.
Yeah, I will have mark Eisner of maybe comment on the respond to that question.
Yeah. So it's a great question. Thank you.
Mark Eisner: Thank you. We can't really obviously share the details of the FDA's overall intent because we don't want to speculate. But we're very confident in our data for both populations. I mean, the data are the same today as they were yesterday.
We can't really obviously share the details of the Fda's overall intent because we don't want to speculate, but we're very confident and our data for both populations and the data are of the same today as they were yesterday and we had the FDA tell us today about the AD com.
Mark Eisner: And we had the FDA tell us today about the outcome. So we continue to feel very confident in the data. And as Enrique said, yeah, I think it's, it's actually, although the timing is unfortunate, it's a great opportunity to really hear from the community, whether they be patients and their advocates, nephrologists, other clinicians about how important and innovative this product is and can be for patients. And there's been very little innovation in this space over the past 30 years for CKD anemia.
So we continue to feel very confident and the data and as Enrique said you know I think it's it's actually although the timing is unfortunate it's a great opportunity to really hear from the community whether they be patients and their advocates.
Nephrologist and other clinicians about how important and innovative of this product is and can be for patients and there's been very little innovation in the space over the past 30 years from C. J D and EMEA and we really believe the rocks and do stock can provide.
Mark Eisner: And we really believe the Roxadu stock can provide really significant clinical benefits to patients in both populations. So, we're looking forward to that discussion in the public venue today. Got it. Thank you. Your next question comes from Di-Fei Yang from Mizuho Securities. Your line is open.
Really significant clinical benefit to patients and both population and so so we're looking forward to that discussion and the public venue.
Got it thank you.
Your next question comes from <unk> Yang from Mizuho Securities.
Di-Fei Yang: Hi, good afternoon, and thanks for taking the questions. So just three quick questions. One, I apologize if I missed that.
And then.
Hi, good afternoon, and thanks for taking the questions.
Quick questions one I promise.
If I Miss back.
Mark Eisner: Will you be, are you expecting the 55-day prep time leading up to EDCOM, or will it be shortened in some fashion? So then the second question is that, would you have the option to call back? CMO for this outcome, or do you think she will not be there?
Will you be are you expecting the 55 day prep time, needing a pure AD com or I will get the shortcut.
And so when does that and then the second question.
And you have the option to claw back.
Yeah, and malls or well the satcom.
She will not be there and then.
Mark Eisner: Then the third question is with regard to EMA. I think you have said you're still expecting a decision mid-year 2021. I'm wondering if you're able to give us a little bit more detail between now and approval, what other things need to happen. I'm going to have Mark Eisner respond to these questions, and I'll compliment him. Right, so in terms of your first question about 55-day prep time, the FDA has not provided us with a date for the advisory committee, and as soon as they do, we'll be able to communicate that, but we would assume that they're going to conform to their typical practices.
And the third thing is with regards to you and I think he would have said you expect.
The expecting decision midyear of 2021.
And.
Wondering if you are able to keep.
Can you play a little bit more detail between now and the approval what other things needs to happen.
Yeah.
I'm going to have Mark Eisner respond to these questions and all of the complementary sensors.
Alright, so in terms of your first question and about 55 day prep time, the FDA has not provided us the date.
For the Advisory Committee and as soon as they do we'll be able to communicate that but we would assume that theyre going to conform to their typical practices in terms of calling back the CMO.
Mark Eisner: In terms of calling back the CMO, Dr. Peoniu will continue to be working as a consultant for us for the next six months, so we'll have access to her expertise, and remember, the expertise on this product, although Dr. Yu is very expert, is deep and broad within both FibroGen and AstraZeneca, so we're very confident that we will be able to bring a very appropriate and invigorated discussion at the time of the outcome, and then in terms of the EMA, yes, there's been no change to our expectations around the mid-year approval for Oxidustat in the European Union. Operator?
Tony you Dr. Peony, Yu will continue to be working as a consultant for us for the next six months. So we'll have access to her expertise and remember the the expertise on this product although Dr. Yu is very expert.
And as deep and broad within both fiber Jen and Austria and the consumer we're very confident that we will be able to bring a very appropriate and invigorated.
Invigorated discussion at the time of the outcome and then in terms of the EMA, Yes, there's been no change to our expectations around the midyear approval of <unk> and the European Union.
Yeah.
Operator.
Okay.
Operator: All right, at this time... I would like to turn it back to the speakers for further comments. I'm not asking any further questions at this time. Please go ahead.
Alright.
At this time.
I would like to turn it back to the speakers for FERC the comments I'm showing no further questions at this time.
Please go ahead.
We appreciate everyone's participation in today's investor call and your interest and five region. Please follow up with our Investor Relations team. If you have any questions. We have not addressed some of the call and enjoy the rest of the day. Thank you.
Enrique A. Conterno: We appreciate everyone's participation in today's investor call and your interest in FibroGen. Please follow up with our investor relations team if you have any questions we have not addressed on the call, and enjoy the rest of your day. Thank you. Ladies and gentlemen, this concludes today's conference call. Thank you for participating.
Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.
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