FibroGen, Inc

Ladies and gentlemen, thank you for standing by and welcome to the FibreGen fourth quarter and full year 2020 financial results conference call. At this time, all participants are in the listen only mode. 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 one on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star zero. I would now like to have a conference over to your speaker today, Mr. Michael Tong. Thank you. Please go ahead.

Thank you, Lyndon. And good afternoon, everyone. I'm Michael Tong, Vice President of Corporate Strategy and Investor Relations at FibreGen. 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, Dr. Mark Eisner, our Chief Medical Officer, Dane Wedig, 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. I would like to remind you that remarks made on today's call include forward-looking statements about FibroGEN. Such statements may include, but are not limited to, our collaborations with AstraZeneca and Astellas, financial guidance, initiation, enrollment, design, conduct, and results of clinical trials, our regulatory strategies and potential regulatory results, our research and development activities, commercial results and results of operations, risks related to our business, and certain other business matters. Each forward-looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in that statement. A more complete description of these and other material risks can be found in Fibergen's filings with the SEC, including our most recent Form 10-K and Form 10-Q. Fibergen 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 investor section of Fibergen's website at www.fibergen.com. With that, I would like to turn the call over to Enrique Quintero, our CEO. Enrique?

Enrique Quintero 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. 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 Roxadustat, 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 panbrevlimab in three high-value indications, locally advanced and resectable pancreatic cancer, Duchenne muscular dystrophy, and idiopathic pulmonary fibrosis. 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 and external opportunities to address unmet medical needs. Today's call will include a review of Roxadustat, our continued strong performance in China, and our clinical trial programs. Let us get started with the Roxadustat New Drug Application, or NDA, review. 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. Just today, we were informed by the FDA that they plan to hold an advisory committee or adcom meeting to review the NDA for Roktadustad in the U.S. We have not received a schedule for the planned adcom. We are surprised by the timing of this request, On three separate occasions, the FDA indicated they were not planning to hold an ADCOM at that time. First, when the NDA filing was accepted, then after the mid-cycle review, and finally after the late-cycle review. It would not be unusual for the FDA to hold an ADCOM for a first-in-class new molecular entity, and as communicated last spring, we were preparing for this possibility. We will now resume those preparation activities and look forward to presenting the comprehensive Roxadustat 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 Roxadustat to patients with an email CKD in the US. As you can appreciate, and has been the case throughout the final stages of review, we will not be able to discuss the details of our FDA interactions. Our pre-commercial activities continued as planned. FibroGen had its largest presence ever at the American Society of Nephrology Kidney Week Conference in October of last year, and there continued to be significant interest in Roxodusta from the clinical community. The momentum generated at ASN continues with additional analysis and plan disclosures of our Phase III data in order to maintain our HIF-PHI scientific and clinical leadership position. Patient and healthcare professional disease education activities are ongoing and expecting to increase through the official launch. Our partner AstraZeneca has a comprehensive renal commercial presence in the U.S., and together we're committed to make Ruxudustat 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 manuscripts covering the phase three studies for CKD anemia to peer-reviewed journals. As you can see on the slide, 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 III data in the coming months. In Japan, our partner Astellas received an additional Evrenso approval for the treatment of anemia of 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 Evrenso. As a result of these two events, Astellas has seen and acceleration in Evrensos uptake. The European Medicines Agency accepted the Roxel-Dustad 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. 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 Roxadusta sales in China for 2020, the first year Roxadusta was included in the NRDL, were $72.5 million. The continuing increase in uptakes is being driven by both an expansion in hospital listings and broad adoption with enlisted hospitals. Hospital listings continue to be a key focus of our launch efforts. Notably, as of the end of the year, Roxadustat was listed at hospitals represented approximately 70% of the CKD anemia market opportunity in China. This is in comparison to 55% at the end of the third quarter. We're driving towards our goal of making Roxadustat the number one treatment option for anemia of CKD patients in China. We continue to see significant Roxodusta utilization across a range of anemia of CKD patient populations. Approximately 60% of patients treated with Roxodusta in China are on dialysis, split between hemodialysis and peritoneal dialysis. Within hemodialysis, initial adoption has been in patients who do not respond well to ESAs, as well as in insulin dialysis patients. The remaining 40% of Roxadustat-treated patients are CKD anemia patients, not on dialysis. 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 Roxadustat the standard of care in treating China's CKD anemia patients. 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 where we have meaningful changes, starting with Roxodustat. We recently completed enrollment in Whitney, our phase two trial in patients with chemotherapy-induced anemia, and top-line data is expected in the second half of this year. Upon conclusion of this trial is successful, we plan to initiate a phase three program in collaboration with AstraZeneca and Astellas. Matterhorn, our phase three trial in patients with anemia of myelodysplastic syndromes, or MDS, continues to enroll with top line data expected in the first half of 2022. Finally, we recently completed enrollment of Aspen and Denali, our two phase three B studies of Roxadustat in CKD anemia with large dialysis organizations in the United States. Moving now to pembrelumab. In locally advanced and resectable pancreatic cancer, 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, enrollment continues in our LELANTUS phase 3 trial, In non-ambulatory patients, we top-line data also expected in the second half of 2022. Finally, in idiopathic pulmonary fibrosis, we recently initiated our Cephris-2 phase 3 trial in December. IPF patients have severely compromised lung function, and the current COVID situation continues to be extremely challenging for enrollment in both our pre-volta trials, Cephris and Cephris-2. 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 enrollment in both trials expeditiously. 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. 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, 2-oxoglutarate enzymology, and connective tissue growth factor, or CTGF, biology in order to advance innovative medicines for the treatment of anemia, fibrotic disease, and cancer. In 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 accomplishment, the hiring of significant leadership talent, which includes the appointments of Dr. Percy Carter, a chief scientific officer, Dr. Mark Eisner, a chief medical officer, and Zane Wettick, a chief commercial officer. In summary, 2020 was a productive transitional year, and I look forward to more progress against our third goal in 2021. I will now turn the call over to our CFO, Pat Cotroneo, for the financial update. Pat?