Edited Transcript of FGEN earnings conference call or presentation 7-May-20 9:00pm GMT

And now I wish to flip the decision over to Enrique Conterno, our CEO. Enrique?

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Enrique A. Conterno, FibroGen, Inc. – CEO & Director [3]

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Thanks, Mike. Good afternoon, everybody, and welcome to our first quarter 2020 earnings name. Given the challenges introduced by the COVID-19 pandemic, I wish to take a second on behalf of FibroGen to reassure sufferers, well being care suppliers, investigators and stakeholders of our continued dedication to carry to sufferers our potential, first-in-class medication for the therapy of continual and life-threatening situations. Governments, companies and society usually, have taken unprecedented measures to mitigate the unfold of the COVID-19 outbreak.

Like many companies, FibroGen has taken numerous actions to help each our workforce and communities in these difficult instances. Within the U.S., our staff are working remotely when attainable. Whereas in China, they’re now again working in our workplaces, manufacturing crops and the sphere. We’ve applied protocols globally to attenuate the danger of sickness for our staff who must work on-site at any of our services.

Regardless of the tough circumstances, we stay dedicated to making sure the regulatory and industrial success of roxadustat, a doubtlessly transformational oral medication in anemia remedy first demonstrated in sufferers with continual kidney illness.

With pamrevlumab, we’re implementing a complete plan to speed up improvement throughout the three indications of idiopathic pulmonary fibrosis, or IPF, domestically superior unresectable pancreatic most cancers, or LAPC, and Duchenne muscular dystrophy or DMD as soon as the scenario with COVID-19 improves.

Lastly, we proceed to advance the innovation of our hypoxia-inducible issue, or HIF, and connective tissue development issue, or CTGF, platforms.

Our enterprise continuity plans are in impact, and we’re seeing an affect to our operations ensuing from COVID-19, we stay assured that FibroGen has the sources and capabilities to navigate by these unsure instances and obtain our said objectives.

As China comes again on-line, we’re persevering with our manufacturing operations and launch efforts there. We’ve ample drug provide to help each the roxadustat launches and medical trials in extra indications in addition to the pamrevlumab medical trials.

We are going to proceed to observe the scenario carefully. To our staff and sufferers and to the thought leaders, clinicians, regulators and numerous others who work together with FibroGen, please know our ideas are with you, and your households.

Now let me start with roxadustat. In the course of the first quarter, our roxadustat NDA submission was accepted by the FDA, and interplay with the FDA on the file continues. We anticipate motion by the PDUFA date of December 20, 2020.

In Europe, the Advertising and marketing Authorization Software submitting for roxadustat for the therapy of anemia in each dialysis- and non-dialysis-dependent sufferers with CKD is predicted within the second quarter of 2020. We and our companions are working diligently in preparation to make this novel, first-in-class medication accessible to as many sufferers worldwide as shortly as attainable.

Turning to China. As , roxadustat was first authorized in China and was included within the Nationwide Drug Reimbursement Record, or NRDL, which went into impact firstly of the 12 months. A key focus has been and continues to be increasing hospital itemizing in order that roxadustat may be extensively prescribed. We noticed constructive momentum in hospital listings in January earlier than the beginning of the COVID-19 restrictions, which brought on a slowdown in new listings from late January to late March. As we stand right here at present, we now have seen a gradual return to a brand new regular in China, and we proceed to be inspired by the roxadustat alternative there.

The COVID-19 pandemic, nevertheless, remains to be inflicting disruption in medical trials throughout the globe. And the FDA, EMA and different regulatory businesses have issued steerage for the conducts of medical trials throughout the pandemic. We’re incorporating these regulatory suggestions as applicable are closed on medical trials.

Our first precedence at FibroGen is guaranteeing the security and well-being of the sufferers collaborating in our research.

Whereas we don’t intend to supply particular particulars on the COVID — on the affect of COVID-19 for every one in all our trials, we will say that we now have seen an affect throughout all of our trials to various levels. Our best trial is pamrevlumab’s ZEPHYRUS IPF trial the place we determined to pause near-term enrollment for the security of sufferers and are presently centered on offering continuous take care of the sufferers who had already been enrolled. The remainder of our trials proceed enrollment, albeit, at a slower price.

In 2020, we’re dedicated to accelerating and increasing the event of pamrevlumab. To that finish, we now have developed a complete plan, which incorporates medical web site activations, geographic enlargement and protocol modification, such that, as soon as issues return to a brand new regular, we may be in the perfect place to speed up enrollment.

Our domestically superior unresectable pancreatic most cancers research continues to enroll. We proceed preparations for ZEPHYRUS 2, our second IPF Section III research, and our Section III program in Duchenne muscular dystrophy is slated to start within the second half of the 12 months.

In abstract, regardless of COVID-19, we proceed to be centered on getting roxadustat authorized within the U.S., advancing pamrevlumab improvement; and eventually, leveraging our experience in each hypoxia-inducible issue, and connective tissue development issue biology to increase our pipeline of novel drug candidates.

Now I’ll flip it over to Peony, who will offer you a extra in-depth dialogue of roxadustat.

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Ok. Peony Yu, FibroGen, Inc. – Chief Medical Officer [4]

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Thanks, Enrique, and good afternoon, everybody. Our 2020 begin has been busy. And at present, I wish to overview among the roxadustat highlights so far this 12 months.

As Enrique talked about earlier, we proceed to anticipate an FDA determination on our roxadustat NDA by the PDUFA date of December 20, 2020. We’ve no indication the FDA will maintain an Advisory Committee Assembly, however we proceed to organize diligently in case, one is scheduled.

To make sure success within the U.S., we and our companion, AstraZeneca proceed commercialization preparations. We plan to submit our Section III particular person research and pool efficacy and security manuscripts for publication over the approaching months.

In Europe, the Advertising and marketing Authorization Software submitting for roxadustat for therapy of anemia in each dialysis- and non-dialysis-dependent CKD sufferers is predicted within the second quarter of 2020.

In Japan, our companion, Astellas, continues the industrial launch of Evrenzo, the Japan model identify for roxadustat for therapy of anemia in dialysis-dependent sufferers. Astellas’ supplemental NDA for anemia in non-dialysis sufferers is presently below overview by PMDA.

We lately introduced new analyses from our Section III roxadustat trials on the annual Nationwide Kidney Basis Spring Medical Assembly.

And the conclusions may be summarized as following: in our non-dialysis sufferers, roxadustat achieved comparable hemoglobin correction with comparable doses no matter iron standing at baseline. Roxadustat therapy resulted in a statistically vital discount in purple blood cell transfusion danger of 74%. 40% of the sufferers on this non-dialysis affected person pool weren’t iron replete or didn’t have adequate iron shops to even qualify for ESA therapy.

Moreover, roxadustat lowered the danger of purple blood cell transfusion and IV iron rescue in comparison with placebo in non-dialysis CKD sufferers, no matter iron standing at baseline.

Lastly, roxadustat considerably lowered the danger of purple blood cell transfusion in dialysis sufferers versus epoetin alfa.

Let me level out roxadustat’s discount of transfusion danger goes hand-in-hand with the superior hemoglobin efficacy achieved in our major endpoint evaluation in comparison with EPO. Roxadustat’s superior hemoglobin change and transfusion discount are accompanied by favorable cardiovascular security outcomes, significantly.

Within the 1,530 affected person incident dialysis pool, roxadustat had a 30% decrease danger of MACE and 34% decrease danger of MACE+ than epoetin alfa. That is extremely related as 86% of U.S. dialysis sufferers have now obtained ESA remedy within the 12 months previous to the initiation of dialysis.

Collectively, these outcomes give us confidence that roxadustat might have a differentiated product profile for dialysis-dependent sufferers. Past CKD, our imaginative and prescient is for roxadustat to turn into the usual of take care of anemia broadly. We proceed improvement of roxadustat for the therapy of anemia related to myelodysplastic syndrome, or MDS, and chemotherapy-induced anemia, or CIA.

We additionally proceed to guage roxadustat for the therapy of anemia related to extra illnesses. Beginning with our Section III international research evaluating roxadustat for the therapy of anemia in MDS, we introduced constructive outcomes from open-label portion of this research at American Society of Hematology 2019 and at the moment are conducting the randomized double-blind placebo-controlled portion of the research. As a reminder, this second portion of the research will enroll roughly 160 transfusion-dependent MDS sufferers in a 3:2 randomization, and the first efficacy measure is % of sufferers who achieved transfusion independence.

Staying within the hematology/oncology area, we even have an ongoing Section II open-label research in CIA, which continues to be an unmet medical want. We are going to proceed to observe, assess and handle the affect of COVID-19 with affected person security as our high precedence. We thank all our investigators for his or her dedication and partnership in growing new therapy possibility for sufferers.

Lastly, in collaboration with our companion, AstraZeneca, roxadustat Advertising and marketing Authorization Software for CKD anemia have been submitted in numerous international locations, together with Canada, Australia, Mexico, Brazil, Taiwan and South Korea.

I’d now like to show the decision over to Chris Chung who will talk about the current developments for roxadustat in China.

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Christine L. Chung, FibroGen, Inc. – SVP of China Operations [5]

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Thanks, Peony. I am excited to share particulars of the constructive progress made throughout the first quarter on the roxadustat launch in China. As a lot of , roxadustat was included within the 2019 Nationwide Reimbursement Drug Record final November. It grew to become efficient January 1 of this 12 months, and the federal government is guaranteeing that rollout is accomplished on an accelerated foundation.

Hospital visitings have been a key focus of our giant efforts and the highest precedence of the AstraZeneca-dedicated roxadustat gross sales workforce. We’re happy with our progress up to now. Roxadustat is now listed and accessible at many hospitals inside our goal universe. We’re significantly happy with the penetration as top-tier Class Three establishments, that are the bigger accounts and in addition the place key opinion leaders and early adopters observe. We consider the hospitals the place we’re listed up to now characterize larger than 30% of the potential CKD anemia market alternative in China.

Roxadustat internet gross sales had been slightly below $5 million for the quarter. Q1 represents the primary quarter after the inclusion of roxadustat in NRDL, and clearly, gross sales had been affected by the COVID-19 pandemic.

From late January by the tip of February, China was basically locked down, and gross sales visits had been fully stopped. Throughout that point, physicians and hospitals had been largely centered on treating COVID-19 sufferers. The variety of non-dialysis outpatient visits had been extremely impacted and dialysis visits had been additionally affected however to a lesser diploma.

Trying ahead to Q2, we anticipate our operations in China to return to a brand new regular, the place social-distancing guidelines will proceed to use. Gross sales representatives at the moment are capable of conduct gross sales visits, and hospital visiting committee conferences are being scheduled. Many types of scientific engagement have moved to digital, the place illness schooling, case discussions and roxadustat expertise of sharing at the moment are being carried out primarily on-line, in a digital method. We’ve seen roxadustat utilization throughout totally different affected person populations, together with hemodialysis, peritoneal dialysis and non-dialysis and in each ESA naive and ESA-treated sufferers.

We proceed to be inspired by the distinctive worth proposition of roxadustat within the therapy of anemia and CKD, particularly, inside the therapy setting in China, given the lowered want for intravenous iron to realize goal hemoglobin ranges, even within the presence of irritation in addition to the oral route of administration.

We stay up for maintaining you up to date as we advance our work in the direction of the long-term objective of constructing roxadustat the usual of care in treating CKD anemia sufferers in China.

I’ll now flip the decision over to Elias who will present an replace on the pamrevlumab program. Elias?

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Elias Kouchakji, FibroGen, Inc. – SVP of Medical Improvement, Drug Security & Pharmacovigilance [6]

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Thanks, Chris, and good afternoon. Immediately, I wish to present an replace on our pamrevlumab program given the COVID-19 improvement over the current months.

As you all know, we’re growing pamrevlumab in Three separate orphan illnesses. On the time of our final earnings name, we had been enrolling ZEPHYRUS, a randomized double-blind, placebo-controlled Section III research evaluating pamrevlumab in IPF and introduced plans to provoke a second comparable Section III trial in IPF named ZEPHYRUS 2.

Given the current COVID-19 pandemic, so as to guarantee affected person security on this weak inhabitants with compromised lung operate, we now have determined right now to quickly pause enrollment of ZEPHYRUS Section III medical research.

The security of our sufferers is our high precedence, as we proceed to evaluate this dynamic scenario and we proceed to work with investigators to supply care and medical trial continuity for sufferers who’re already enrolled on this trial. Previous to posing enrollment, we had been centered on accelerating enrollment of our ongoing ZEPHYRUS Section III research in getting ready to provoke the ZEPHYRUS 2 trial. To the extent attainable, we proceed these preparations, resembling after we are capable of restart enrollment, we are going to hit the bottom operating.

Transferring on to our domestically superior unresectable pancreatic most cancers, or LAPC, program. LAPIS is our ongoing randomized double-blind, placebo-controlled Section III trial in sufferers with LAPC. As , these sufferers have a fantastic prognosis, and we’re working with our investigators and medical trial web site employees to implement modifications, which mitigate the danger to affected person and adjust to regulatory and authorities steerage.

We proceed to organize to provoke a Section III trial, LELANTOS, evaluating pamrevlumab as a therapy for Duchenne muscular dystrophy, or DMD, within the second half of 2020. There’s a vital curiosity for DMD well being from the DMD well being care suppliers and affected person communities. This international trial shall be a randomized double-blind, placebo-controlled Section III trial of pamrevlumab in sufferers with non-ambulatory DMD. It’s going to enroll roughly 90 sufferers randomized 1-to-1 to placebo and have a therapy interval of 52 weeks.

Now I’ll flip the decision over to our CFO, Pat Cotroneo, for the monetary replace. Pat?

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Pat Cotroneo, FibroGen, Inc. – Senior VP of Finance & CFO [7]

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Thanks, Elias.

As introduced at present, complete income for the primary quarter of 2020 was $24.Four million as in comparison with $23.9 million for the primary quarter of 2019. The present quarter income consists of $19.Four million in improvement income plus internet product revenues of $5 million for roxadustat gross sales in China. For a similar interval, working prices and bills had been $105.5 million and internet loss was $78.Three million or $0.89 per primary and diluted share as in comparison with working prices and bills of $72.7 million and a internet lack of $45.Four million or $0.53 per primary and diluted share for the primary quarter this 12 months.

Included in working prices and bills for the quarter ended March 31, 2020, was an mixture noncash portion totaling $22.1 million, of which $16.9 million was a results of stock-based compensation expense as in comparison with an mixture noncash portion of $20.Four million, of which $16.Four million was a results of stock-based compensation expense for a similar interval within the prior 12 months.

At March 31, FibroGen had $598.Four million in money, money equivalents, restricted time deposits, investments and receivables.

As beforehand said, in accordance with the U.S. GAAP, we acknowledged in our Q2 2019 monetary outcomes a complete of $180 million of milestone funds, when achievement grew to become possible. The quantity was comprised of $50 million for anticipated milestone from AstraZeneca associated to the submitting of the U.S. NDA, which was obtained on April 1, 2020, and $130 million in anticipated milestones from Astellas in reference to the EU MAA filings, which we anticipate to happen within the second quarter this 12 months.

Primarily based on these milestone funds and our newest forecast knowledge, we proceed to estimate our 2020 ending money steadiness of money, money equivalents, restricted time deposits, investments and receivables to be within the vary of $720 million to $730 million, assuming U.S. NDA approval in This autumn 2020.

Trying forward, we now have a complete of $375 million in anticipated milestones anticipated over the subsequent 15 months for the U.S. and Europe, which incorporates the aforementioned $130 million of milestones for MAA submissions, plus $245 million of milestones on approvals and first industrial sale.

At this cut-off date, we now have no modifications in expectations in any of the anticipated milestones over the subsequent 15 months.

Thanks. And I’d now like to show the decision again over to Enrique.

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Enrique A. Conterno, FibroGen, Inc. – CEO & Director [8]

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Thanks, Pat. In closing, FibroGen is properly positioned to navigate these unsure instances. We and our companions are dedicated to creating roxadustat accessible to as many sufferers throughout the globe as shortly as attainable. We’ve ample provide of roxadustat drug product to fulfill demand for the 12 months and ample provide of pamrevlumab for our deliberate medical trials.

As roxadustat gross sales ramp up, our monetary place is robust with roughly $600 million in money on the finish of the primary quarter. We’ve a complete of $375 million in anticipated milestones anticipated over the subsequent 15 months within the U.S. and Europe, which incorporates $130 million of milestones for the MAA submitting, plus $245 million of milestones on approvals and first industrial sale.

As well as, we obtained full-partner reimbursements for improvement and commercialization of roxadustat in all geographies, besides China, the place we share these bills 50-50 with AstraZeneca. Primarily based on our present forecast, we’re reiterating our estimated 2020 ending money to be within the vary of $720 million to $730 million and proceed to consider we’re properly financed for years to return.

Now I wish to flip the decision again to the operator for questions. Operator?

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Questions and Solutions

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Operator [1]

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(Operator Directions) Our first query comes from Michael Yee with Jefferies.

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Michael Jonathan Yee, Jefferies LLC, Analysis Division – Fairness Analyst [2]

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Enrique, Peony, guys, two questions from me, should you can hear me, okay?

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Enrique A. Conterno, FibroGen, Inc. – CEO & Director [3]

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Sure.

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Michael Jonathan Yee, Jefferies LLC, Analysis Division – Fairness Analyst [4]

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There was lately some competitor knowledge that got here out this week. Possibly you possibly can simply discuss methods to put that into context. Importantly, within the dialysis phase, they solely had 10% of the inhabitants and incident, the place you had, I believe, upwards of 40%, but you guys have the identical hazard ratio of 0.96. So possibly discuss to that knowledge set? And what that may imply, each in incident dialysis and steady dialysis, if you attempt to evaluate that knowledge? After which my second query is on China. Chris, I assumed you had some good feedback there. Possibly discuss the way you anticipate Q2, 3, Four to ramp as persons are modeling gross sales.

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Enrique A. Conterno, FibroGen, Inc. – CEO & Director [5]

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Superb. Thanks very a lot, Michael, for the questions. I’ll flip over the query on the current competitor knowledge to Peony, however let me simply make a touch upon that. Clearly, this knowledge validates HIF-PHIs, I believe, in an essential means. However I am excited for us to have the ability to additionally share why are we so enthusiastic about roxadustat by way of the differentiation.

And we are going to then go to Chris to your questions in China by way of gross sales ramp-up. Peony?

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Ok. Peony Yu, FibroGen, Inc. – Chief Medical Officer [6]

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Thanks, Enrique, and thanks, Mike, for asking the query. Current knowledge reaffirms the security of the HIF class, as Enrique mentioned. As well as, we’re reassured that the roxadustat product profile is compelling. It is a nice alternative to remind us in regards to the differentiating elements of roxadustat.

From an efficacy standpoint, roxadustat is numerically and statistically superior in hemoglobin efficacy endpoint, which then, in flip, interprets into medical advantage of discount of transfusion in dialysis sufferers. Our major efficacy endpoint of change from baseline to weeks 28 to 52 was superior to an energetic comparator after we met noninferiority comparability. And the P-value is lower than 0.001.

Now what could be very — we even have statistically vital discount in transfusion danger. Importantly, we now have demonstrated cardiovascular security within the total dialysis inhabitants and in MACE. And moreover, we demonstrated a discount in MACE+ danger. In our 1,530-incident dialysis affected person pool, the place the comparability between roxadustat with epoetin alpha began inside the first Four months of dialysis initiation, roxadustat had a 30% decrease danger of MACE and 34% decrease danger of MACE+ than epoetin alfa, with a pattern in the direction of decrease or trigger mortality, relative to epoetin alfa. Now this can be a highly-relevant inhabitants. The distinction between the incident dialysis and the steady dialysis is that, incident dialysis describes the purpose of entry, timing of the entry into the research. Sufferers — this contains sufferers who’ve began dialysis inside Four months of research enrollment and proceed receiving therapy properly into steady interval as the typical therapy is round 2 years.

And to handle the query of — that you’ve introduced up about steady dialysis, the opposite subgroup of the all dialysis sufferers are sufferers who entered the research on the time that they’ve been on dialysis for greater than Four months and continued therapy. After we take a look at the transformed sufferers or the steady dialysis sufferers and consider and taking a look at security — cardiovascular security, it doesn’t change any of the conclusions that we now have on the — about roxadustat being protected and efficacious.

And so in conclusion, roxadustat, glorious cardiovascular security profile, coupled with the statistically vital and clinically significant, larger hemoglobin efficacy outcomes and decrease transfusion price relative to epoetin alfa, collectively makes roxadustat doubtlessly a greater therapy possibility for dialysis-dependent sufferers. We just like the hand that we now have and anticipate the product label to mirror the outcomes of medical trials on our compound.

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Michael Jonathan Yee, Jefferies LLC, Analysis Division – Fairness Analyst [7]

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I recognize the query as a result of, sure — due to the steady inhabitants and doing the maths round that versus them. So incident is essential, and I recognize the response. And possibly Chris, on China?

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Enrique A. Conterno, FibroGen, Inc. – CEO & Director [8]

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Chris?

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Christine L. Chung, FibroGen, Inc. – SVP of China Operations [9]

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Sure. Mike, so we proceed to be optimistic about second, third and fourth quarter. The way in which to take a look at the numbers is perhaps, you noticed the This autumn numbers and also you noticed the Q1 numbers. So what does the Q1 numbers let you know? So there’s seasonality by way of when the issues usually are available in, in China. In order , with out listings, you can’t prescribe. So this stuff are key, but additionally, there’s super momentum popping out of NRDL to record as a result of it makes the drug reasonably priced and it makes hospitals desires a listing. So we’re very pleased with the Q1 numbers. It displays momentum popping out of NRDL. It displays a little bit of a slowdown due to COVID. We’re now popping out of COVID into new regular. It is a little bit bit touch-and-go, so it is onerous to foretell based mostly on it, however we proceed to be very optimistic in what the remainder of the 12 months seems to be like.

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Operator [10]

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And our subsequent query comes from Geoffrey Porges with SVB Leerink.

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Geoffrey Craig Porges, SVB Leerink LLC, Analysis Division – Director of Therapeutics Analysis & Diversified Biopharma and Senior Analysis Analyst [11]

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In NDT versus DD, I am curious, Chris, to begin with, in China, what’s your evaluation of how this can play out over the long run? Hypothetically, do you assume that they are roughly equal? Or do you assume that one goes to finally be considerably bigger than the opposite?

After which, Enrique, I do know you are not answerable for commercialization, however I would love to listen to your coloration on what you assume the scenario shall be within the U.S. once more? Do you assume that the chance shall be bigger in dialysis, given your incident dialysis knowledge? Or do you assume that the larger alternative shall be getting the non-dialysis declare?

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Enrique A. Conterno, FibroGen, Inc. – CEO & Director [12]

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Superb, Geoff. Let me attempt to deal with each of your questions. Trying on the relative measurement of each dialysis and non-dependent-dialysis, clearly, the variety of sufferers which have anemia, and which might be on dialysis is critical, however the alternative to assist sufferers in non-dependent-dialysis is, in fact, a lot, a lot bigger. I view each alternatives as essential alternatives. However over time, I view the chance in non-dialysis-dependent sufferers to be a lot bigger than the chance within the dialysis. In fact, we might want to do our job to make sure the sufferers are accessing therapy for anemia, sufferers which have CKD.

With regards to the U.S., I do know you give in a minute this manner, however I’m fully engaged in terms of guaranteeing that we will have a profitable commercialization of roxadustat. And I had the chance to interact, in fact, with AstraZeneca. The scenario there follows, I believe, comparable feedback in China being the NDD alternative over time, has a possible to be considerably bigger as we develop that market and we be certain that sufferers are handled. Take into account that after we take a look at sufferers coming in to dialysis at present and we take a look at the prior 12 months, solely about 14% of them are handled for anemia in these prior 12 months. So a fantastic alternative, I believe, to make sure that many, many sufferers get appropriately handled and clearly, an enormous alternative for market enlargement there.

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Operator [13]

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Our subsequent query comes from Jason Gerberry with Financial institution of America.

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Jason Matthew Gerberry, BofA Merrill Lynch, Analysis Division – MD in US Fairness Analysis [14]

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Sure. Simply curious, should you can remark in your 2020 roxa publication technique. I think about your competitor shall be seeking to make a splash in ASN later this 12 months. And so, I do know that there is some knowledge factors concerning the roxa program, as an illustration, the info on the MACE subcomponents for the DD research. Simply curious, if we might get any extra incremental knowledge printed out of you guys later this 12 months? And should you can remark in any respect on that entrance. After which possibly only a follow-up for Chris. Assist us take into consideration the $5 million quantity for China this quarter. Is {that a} pure demand-driven quantity? I assume, inclusive of the COVID headwind. You talked about 30% of hospitals have entry to roxa, however I believe in prior conversations, you talked in regards to the NDD market requiring extra market constructing. So ought to we take into consideration that entry as being extra across the DD alternative, a minimum of on the onset?

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Enrique A. Conterno, FibroGen, Inc. – CEO & Director [15]

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Sure. Thanks, Jason, for the query. I’ll ask Peony to touch upon our publication technique. We’re excited in regards to the publications that we’re — publication planning, what we’re attempting to do that 12 months. After which I’ll ask Chris to offer us some extra coloration on China. Peony?

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Ok. Peony Yu, FibroGen, Inc. – Chief Medical Officer [16]

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Sure. I’m very enthusiastic about our upcoming publication plans. We might — I can say that we’re data-rich, and we’re working very carefully with our 2 companions, Astellas and AstraZeneca, to — we’re dedicated to submit our Section III particular person research in addition to pool efficacy and security manuscripts for publications over the approaching months. We additionally plan to submit numerous abstracts to ASN, which shall be held in October of this 12 months. Keep tuned.

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Enrique A. Conterno, FibroGen, Inc. – CEO & Director [17]

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I am — sure, Chris, should you might please reply the query on China, present little extra coloration.

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Christine L. Chung, FibroGen, Inc. – SVP of China Operations [18]

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Completely. So Jason, you requested if the $5 million is a pure demand quantity? So the reply is not any. The $5 million represents ex manufacturing unit revenues from FibroGen Beijing into the channel. Particularly, it represents internet revenues, which is orders minus VAT, which is 13%, internet or distributor’s reductions, incentives, commissions. So it is actually a pure internet numbers into the channel. The distinction between the channel stock, the demand quantity is the hole. So this isn’t a requirement quantity. It is a internet ex manufacturing unit quantity.

The second query, Jason, I consider you requested is whether or not this represents extra DD versus NDD. So what we now have seen to this point could be very according to what Enrique mentioned simply now. In the long run, the NDD market has extra sufferers, and we will have a big affect in that affected person inhabitants as a result of they’re presently both not handled or undertreated. However that could be a market we have to construct. For DD, it is a substitution market. It is a very well-established normal of care and therapy sample, the place both persons are changing from normal of care to HIF-PHIs or incident sufferers are beginning with HIF-PHI. We’ve seen adoption throughout all of the affected person varieties, which is hemodialysis, peritoneal dialysis and really encouragingly, non-dialysis. So the quantity you are seeing by way of revenues is shift in from our manufacturing unit into the channel based mostly on demand from HD, PD and NDD.

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Enrique A. Conterno, FibroGen, Inc. – CEO & Director [19]

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If I — sure, if I might simply complement a bit. As , Jason, I had duty for China as properly, once I was at Lilly. To have the ability to have principally a 30 — entry to 30% of the general market alternative post-NRDL itemizing, I believe, could be very vital. So we — that is a fantastic progress. We used to take firms post-NRDL itemizing principally years to have the ability to have significant market entry alternative in China. I believe that is extraordinarily encouraging. I do wish to make sure that, there wasn’t something, whereas the $5 million are simply the ex FibroGen sale, internet gross sales, there’s nothing uncommon in terms of stocking. The stocking was very regular for the quarter. And I’d say, as we take a look at Q2, Q3 and This autumn, we do anticipate a significant ramp-up.

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Operator [20]

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And our subsequent query comes from Adam Walsh with Stifel.

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Xiaodong Zhang, Stifel, Nicolaus & Firm, Integrated, Analysis Division – Affiliate [21]

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That is Edwin on for Adam. First one, on COVID-19. We all know there are printed research exhibiting that COVID-19 sufferers, even those that have recovered are affected by lengthy injury, together with fibrosis. So do you have got any plans to discover pamrevlumab or different pipeline property on this COVID-19 affected person? And I’ve a follow-up, if I’ll.

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Enrique A. Conterno, FibroGen, Inc. – CEO & Director [22]

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Sure. Thanks to your query, Adam. I’ll ask Elias to remark, however simply we’re planning to check pamrevlumab in hospitalized sufferers with COVID-19. And we see 2 potential functions within the acute setting, to enhance oxygenation and in addition within the post-acute setting, to ameliorate lung fibrosis.

I’ll ask now Elias to make a couple of extra feedback or causes to why we’re enthusiastic about this extra alternative to have the ability to assist sufferers with COVID-19. Elias?

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Elias Kouchakji, FibroGen, Inc. – SVP of Medical Improvement, Drug Security & Pharmacovigilance [23]

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Thanks to your name. In order Enrique is saying, we’re taking a look at these research presently, and we’re discussing these research with regulators, such because the FDA and different European regulators. We’re shifting ahead with planning for these research. And the distinction is, as we all know, there’s 2 phases of the COVID-19: the acute section, the primary 15 days; and the residual section. Within the acute section is — there’s a massive lack of oxygenation, which is clearly, is essential half that’s resulting in loads of difficulties in treating these sufferers. Pamrevlumab is — can have some impact. We’ve some knowledge that to point out, that’s — we will have an effect on the leakage on the stage of the vessels in [introduced] edema and would possibly facilitate oxygenation. And the long-term mentioned that this affected person is exhibiting interstitial lung fibrosis and lung illness, particularly after the Acute Respiratory Misery Syndrome. In IPF, we now have proven our good results on fibrosis, and we consider that this doubtlessly that CTGF is equally is affecting fibrosis, which we all know it’s from our radiation-induced lung fibrosis that we will decelerate or cease that development of the fibrosis. And we’re planning ahead to debate these research quickly and planning to maneuver ahead with them.

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Xiaodong Zhang, Stifel, Nicolaus & Firm, Integrated, Analysis Division – Affiliate [24]

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Nice, nice. My subsequent one. Earlier this week, a competitor discloses higher bounce of noninferiority margin of 1.25, which is agreed by the FDA. Ought to we assume that it’s the — you — maintain you to the identical normal or overview and approval?

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Enrique A. Conterno, FibroGen, Inc. – CEO & Director [25]

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Sure. Thanks. I’ll attempt to reply this beautiful shortly. I believe we now have as said this earlier than. We really feel that the general cardiovascular knowledge that we principally have on each DD and NDD is kind of compelling. And we really feel that roxadustat presents an essential — has an essential profit danger ratio. As we said earlier than, questions on noninferiority shall be part of a overview determination for roxadustat, however we really feel very assured by way of what we now have been capable of present and the profit danger profile that the product has.

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Operator [26]

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And our subsequent query comes from Yaron Werber with Cowen.

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Yaron Benjamin Werber, Cowen and Firm, LLC, Analysis Division – MD & Senior Biotechnology Analyst [27]

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And congrats on China. I imply it seems to be prefer it’s off to a very terrific begin. I had a fast query regarding — possibly simply your ideas, and I do not know should you can remark a little bit bit forward into the U.S. launch, early subsequent 12 months, within the dialysis setting and particularly, with the good thing about TDAPA. With TDAPA medication like roxa ought to, as soon as included, have a monetary incentive to get used. Earlier, I believe it was final week, Amgen famous that Parsabiv has seen a good uptick in small and form of medium-sized dialysis clinics, however a lot — face a lot greater headwind form of actually entering into DaVita and Fresenius. So ideas about, form of how would you sort out that to make roxa form of extra engaging for them. After which I’ve a fast follow-up as properly.

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Enrique A. Conterno, FibroGen, Inc. – CEO & Director [28]

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Sure. Thanks. I believe — thanks to your query. Clearly, TDAPA presents, I believe, an incentive to guarantee that revolutionary merchandise are included as a part of the therapy protocol for dialysis facilities. And I believe it is designed for a product resembling roxadustat.

Simply to possibly communicate a little bit bit in regards to the course of. As soon as we obtain approval, we must submit for — to be reimbursed below this technique, this TDAPA system. We anticipate that inside Three months, we will get that designation. And clearly, as we take into consideration that, similar to we shall be getting ready for any launches, clearly, on this specific case, the big dialysis organizations are key by way of their adoption, and you may be reassured that we’re, and AstraZeneca, is working carefully with them to make sure that we will have the perfect adoption attainable and be certain that innovation is included within the therapy of sufferers within the dialysis facilities, and that’s included quick. So I can not communicate for different firms, however I be ok with the plans and the way we’re solidifying these plans now.

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Yaron Benjamin Werber, Cowen and Firm, LLC, Analysis Division – MD & Senior Biotechnology Analyst [29]

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Okay. And simply one other query. At typically, Peony, I believe possibly you touched upon this, do you have got plans to launch the info for the prevalent dialysis by itself? I imply you have completed actually a terrific job exhibiting us the incident dialysis knowledge and total dialysis. And simply curious in regards to the prevalent dialysis as that accounted for about 80% of sufferers out there.

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Enrique A. Conterno, FibroGen, Inc. – CEO & Director [30]

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Sure. I’ll ask Peony to handle the query. I assume it’s speaking in regards to the steady dialysis. Peony, any — what are our plans in terms of releasing that specific knowledge?

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Ok. Peony Yu, FibroGen, Inc. – Chief Medical Officer [31]

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Sure. As I discussed, our incident dialysis knowledge additionally comprises prevalent dialysis knowledge in that. Incident was the primary Four months, that is the entry into the research, and sufferers proceed receiving therapy. And so they’re the prevalent sufferers. And I’ve talked about earlier that we now have seemed on the sufferers who — the steady dialysis or the prevalent dialysis sufferers who’ve been on dialysis for 4 — greater than Four months on the time that they enter our Section III research. And we’re very snug with the efficacy and the security knowledge in that subgroup. And that is — the outcomes doesn’t change our conclusion or confidence about our product. And there, it is vitally seemingly that we’ll — we might share this knowledge, and I wished to remind ourselves that, that was not essentially a — that evaluation was not a prespecified evaluation. And so we’re nonetheless snug with it. And an important, to bear in mind is that the general knowledge, total dialysis, which was the prespecified evaluation and that we now have already disclosed that and reiterate that the 86% of the sufferers who begin dialysis haven’t had obtained any ESA therapy for the anemia. And subsequently, incident dialysis the place we take these sufferers inside the first Four months into the research, and we think about that knowledge to be extremely related. And we consider that we might have the biggest incident dialysis affected person pool in CKD anemia packages.

I am sorry. Enrique, did you wish to add one thing?

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Enrique A. Conterno, FibroGen, Inc. – CEO & Director [32]

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Sure. Thanks, Peony. I — the one factor that I wished so as to add Yaron, was you talked in regards to the incident dialysis being 20% of the market. I believe it is — that is right for the primary 12 months, proper? You are considering of — however sadly, the mortality of sufferers in dialysis could be very excessive. So having a product that’s differentiated in incident dialysis is provided that it is a pure level for a therapy determination, in terms of anemia beginning dialysis. We discovered it is significantly essential so as to have desire for that therapy. And we consider that roxadustat is uniquely — goes to be uniquely positioned there. Thanks.

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Operator [33]

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And our subsequent query comes from Paul Choi with Goldman Sachs.

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Kyuwon Choi, Goldman Sachs Group Inc., Analysis Division – Fairness Analyst [34]

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Possibly my first query is for Peony and almost about the double-blind portion of the Section III MDS trial. Are you able to possibly simply touch upon — are you seeing — fascinated with any potential impacts to time strains, simply provided that the sufferers need to be conditioned for his or her MDS therapy earlier than doubtlessly receiving roxa? After which, I had a follow-up on Europe.

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Enrique A. Conterno, FibroGen, Inc. – CEO & Director [35]

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Peony, go forward.

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Ok. Peony Yu, FibroGen, Inc. – Chief Medical Officer [36]

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Sure. I wished to make clear that not like — look, a [matter of] product trial, by way of trial design, our MDS trial contains sufferers who’re treatment-naive and those that have failed ESA. After which, we’re additionally contains sufferers who’re ring sideroblast constructive and ring sideroblast destructive. The trial is a worldwide research and embrace research websites and sufferers within the U.S. and in Europe. I hope that solutions.

After which, we at the moment are on the double-blind, placebo-controlled portion of the research. And as you alluded to, I simply wished additionally remind ourselves that we now have a share of very encouraging constructive knowledge of the open-label phase of this research on the American Society of Hematology in 2019. I hope that answered the query.

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Kyuwon Choi, Goldman Sachs Group Inc., Analysis Division – Fairness Analyst [37]

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I assume possibly to place it differently, Peony, simply given the scenario with COVID and the danger to MDS sufferers, who need to undergo chemotherapy or conditioning, do you see any modifications to the time line to your Section III?

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Ok. Peony Yu, FibroGen, Inc. – Chief Medical Officer [38]

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Oh, okay. Now I wished — truly, there’s a little affect on our trial — on a Section III trial for the next causes, as a result of now the sufferers we enroll are already transfusion-dependent. So they’re — they do must be monitored and handled by their doctor, or in different phrases, they’re tethered to the well being care system. And participation in our trial, the place we offer an oral remedy to scale back the danger of transfusion, it is view, should you can take into consideration this — give it some thought this manner, that it may very well be favorable, if sufferers might have much less — would require much less transfusion. That may translate into much less publicity danger. Does that make sense?

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Kyuwon Choi, Goldman Sachs Group Inc., Analysis Division – Fairness Analyst [39]

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Sure. That is useful. After which concerning Europe, as you are approaching the MAA right here within the coming — finish of this quarter, and as you look possibly on the ahead right here and take into consideration commercialization, simply with regard to the totally different European views on utilizing roxa within the 2 populations, are you able to possibly touch upon the way you anticipate adoption would possibly go there between your self or what your companion would possibly see as you consider the early launch curve there?

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Enrique A. Conterno, FibroGen, Inc. – CEO & Director [40]

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Sure. Clearly, as we now have said, we predict submitting in Europe this second quarter. And clearly, as , in terms of Europe, totally different markets behave in a different way. It is a good query for Astellas, however we have to remember the fact that in some markets, you may make the product — you possibly can launch the product immediately, like in Germany and so forth. In another markets, you should undergo — be capable to get some reimbursement. So there’s going to be a market-by-market determination, and we stay up for serving to as a lot as we will, Astellas as they’re actually the drivers in terms of commercialization, in fact, in Europe.

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Operator [41]

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And our subsequent query comes from Difei Yang with Mizuho.

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Unidentified Analyst, [42]

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That is Alex on for Difei. I used to be questioning should you might remark a little bit bit on the NDD setting within the U.S. Particularly, I used to be desirous about — should you might discuss what’s the normal of care there? How are ESAs used at present? And what do you assume are the advantages of getting a placebo comparator in that setting? After which together with that, I used to be questioning whether or not or not you’d anticipate the black field warning on approval?

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Enrique A. Conterno, FibroGen, Inc. – CEO & Director [43]

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Superb. I’ll attempt to go this to Peony. I will attempt to reply the final a part of your query. Clearly, I believe what we mentioned is that the info, the info that we now have, we don’t consider desires a black field, however this can be a determination for the regulators. I’ll ask Peony to touch upon NDD and the usual of care. Sadly, many sufferers usually are not handled for anemia that do have anemia. And so there’s a chance for — to enhance the therapy price. However Peony, you possibly can discuss the usual of care and possibly present some coloration in the USA.

Peony?

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Ok. Peony Yu, FibroGen, Inc. – Chief Medical Officer [44]

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Sorry, I simply — thanks for reminding me to be unmuted. So thanks for the query. We do consider that non-dialysis-dependent sufferers, anemia is essentially an unmet medical want, and this presents a fantastic alternative for roxadustat to enhance care on this inhabitants. What I imply by that’s that due to cardiovascular security concern of ESA, their therapy of non-dialysis sufferers with ESA is restricted to maintaining hemoglobin lower than 10. And within the literature, there’s intensive proof that maintaining sufferers hemoglobin lower than 10 is related to larger transfusion danger. And so there’s well-known that, because the label change in ESA in 2011 that the transfusion price has gone up within the non-dialysis sufferers, together with the discount within the therapy price of non-dialysis sufferers. And that is mirrored by the USRDS knowledge of solely about 13.5% of the sufferers getting into dialysis have been uncovered to ESA within the 12-month prior.

What does this translate for roxadustat? That is the primary motive that we now have chosen placebo because the comparator, since no care is the usual of care within the U.S. And in our Section III program, we now have demonstrated a big improve in hemoglobin stage in comparison with placebo and importantly, considerably lowered transfusion to solely about 1/Three of the placebo. And now in — and our therapy resulted in hemoglobin at round 11, and this was our therapy objective.

And so I additionally wished to level out that placebo comparator presents as a comparator is a excessive bar for comparability for cardiovascular security as a result of, if one had been to decide on ESA, that — as an agent, that already has a field warning for cardiovascular security. However placebo is the gold normal. With — compared to placebo, we now have demonstrated that cardiovascular security within the MACE endpoint and MACE+ endpoint.

Lastly, lastly, our discuss doesn’t — in our program, 40% of our sufferers weren’t iron repleted, which is a requirement for ESA. So not solely can we deal with the sufferers to a extra therapeutic stage of hemoglobin and scale back transfusion, we’re going to have the ability to increase therapy to extra sufferers, even once they’re — they do not have as a lot iron round. Thanks.

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Enrique A. Conterno, FibroGen, Inc. – CEO & Director [45]

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Superb. Thanks, Peony. And I do know that we’re — we now have already prolonged our time. So I wish to thank everybody for becoming a member of our name and for your entire help of FibroGen. Thanks. Thanks very a lot.

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Operator [46]

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Girls and gents, this concludes at present’s convention name. Thanks for collaborating, and it’s possible you’ll now disconnect. Everybody, have a fantastic day.