FibroGen, Inc

Good day and thanks for your standby. Welcome to the private gen second quarter 2021 financial results conference call. At this time, all participants are in listen on the moon. 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 the star one on your telephone keypad. If you require any further assistance, please press the star zero. As a reminder, this conference call is being recorded. I'd now like to turn the call over to Mr. Michael Tong. Please go ahead.

Thank you, Charlie. Good afternoon, everyone. Welcome to FibreGen's 2021 second quarter conference call. I'm Michael Tong, Vice President of Corporate Strategy and Investor Relations at FibreGen. Joining me on today's call are Enrique Quintero, our Chief Executive Officer, Pat Cotroneo, our Chief Financial Officer, Dr. Mark Eisner, our Chief Medical Officer, Dr. John Hunter, our Chief Scientific Officer, Thayne Wettig, our Chief Commercial Officer, and Chris Chung, our Senior Vice President of China Operations. 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 may include forward-looking statements based on FibroGen's current expectations. Such statements may include statements regarding to, but not limited to, our research and development activities, the initiation, enrollment, design, conduct, and results of clinical trials, our regulatory strategies and potential regulatory results, anticipated FDA interactions, commercialization and results of operations, risks, plans, market opportunity, and strategy related to our business, our collaborations with AstraZeneca and Astellas, financial guidance, and certain other business matters. Such forward-looking statements are subject to significant risks and uncertainties that could cause actual results to differ materially from those anticipated in such statements. For discussion of these and other material risks and factors that could affect our future financial results in business, please refer to The disclosure in today's press release reporting our fiscal 2021 second quarter financial results and business update, our most recent Forms 10-K and 10-Q, and reports that we may file on Form 8-K with the Securities and Exchange Commission. All our statements are made as of today, August 9, 2021, based on information currently available to us, and FibreGen does not undertake any obligation to update publicly any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. Today's press release reporting our fiscal 2021 second quarter financial results in a business update and a webcast of today's conference call can be found on the investor section of FibreGen's website at www.fibregen.com. With that, I would like to turn the call over to Enrique Quintero, our CEO. Enrique.

Thank you, Mike, and good afternoon, everyone, and welcome to our second quarter 2021 earnings call. Today, I would like to provide a high-level summary of important accomplishments and developments in recent months. Pat Cotroneo, our CFO, will then review the financials, after which we will open up the call for your questions. There is no question we are facing a significant challenge given the recent FDA Advisory Committee vote. However, Fibrogen continues to be positioned to create significant value for patients and shareholders by executing on the three areas of focus as shown on slide three. 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 also with significant potential for expansion to treatment of additional indications. Number two, developing Pambrelumab in three indications with significant unmet medical need, locally advanced and resectable pancreatic cancer, Duchenne muscular dystrophy, and idiopathic pulmonary fibrosis. And number three is strengthening research productivity by leveraging our leadership position both in hypoxia-inducible factor and connective tissue growth factor biology and by accessing external innovation. Today's call will include an update of the regulatory status of Roxodustat, our continued strong performance in China, our clinical trial programs, and recent corporate developments. Let us get started with Roxadustan on slide four. In June, the CHMP of the European Medicines Agency adopted a positive opinion relating to the use of Roxadustan for the treatment of anemia associated with CKD. We expect a decision from the European Commission by the end of August. In July, the FDA Cardiovascular and Renal Drugs Advisory Committee voted to recommend not approving Roxadustat for the treatment of anemia of CKD. We and our partner, AstraZeneca, are in dialogue with the FDA and expect an action in the near future. During the quarter, Roxadustat was approved in South Korea to treat adult patients with anemia of CKD, and we have regulatory submissions in other territories under review. To support commercialization efforts worldwide, we have submitted manuscripts covering all primary phase three studies to peer-reviewed journals. As noted in slide five, 70 of these manuscripts have been published, encompassing both non-diagnosis-dependent and dialysis-dependent data. and we expect additional publications of the phase three data in the coming months. Moving now to China. As you can see on slide six, we are pleased to report total of the booster net sales to distributors in China of $52.8 million for the second quarter and $96.3 million for the first half of 2021. The increase in uptake continues to be driven by both an expansion in hospital listings and broad adoption within listed hospitals. Fabergen reported $13.4 million in China Roxadusta net product revenue for the second quarter of 2021 and $28.7 million for the first half of 2021. Hospital listings continue to be a key focus of our launch efforts, and at the end of the second quarter, Roxadusta was listed as a hospital that collectively represents approximately 81% of the CKD anemia market opportunity in China. As you can see on slide seven, the ESA market growth has accelerated since the inclusion of Roxadustat on the NRDL. In fact, ESA revenue over the last six months has shown meaningful growth over the same period in the prior year. Moving to slide eight, Roxadustat has driven the expansion of the anemia of CKD category over the past year and a half. In fact, Roxodustad captures 70% of the category growth and is capturing share in an expanding market. Finally, as shown on slide nine, Roxodustad is the number one branded treatment for anemia of CKD in China for the past five months, achieving a value share of 32% in the most recent month within the segment that includes all ESA products on roxacustat, currently the only HIF-PHI in the market. We look forward to keeping you updated as we advance our long-term goal of making roxacustat the standard of care in treating China's CKD anemia patients. Moving now to our clinical development programs on slide 10. COVID continues to create challenges to recruitment And today, we are updating our timelines, starting with Roxadustat. We recently completed Whitney, our Phase II trial in patients with chemotherapy-induced anemia, and look forward to sharing top-line data with you later this quarter. Top-line data of Matterhorn, our Phase III trial in patients with anemia or myelodysplastic syndromes, or MDS, is now expected to in the second half of 2022 or first half of 2023 versus prior guidance of the first half of 2022. In China, the blinded portion of the phase three trial of Roxadustad in patients with anemia of MDS has begun enrollment. Moving now to panbrevlimab, in locally advanced and resectable pancreatic cancer, an interim analysis of event-free survival for potential accelerated approval of our LAPIS phase III trial will be completed in the second half of 2022. Previously, the refraction rate was a surrogate endpoint for accelerated approval. After recent discussions with the FDA, we changed this endpoint to the event-free survival endpoint, which is composed of progression, death, and resection failure due to progression. This better reflects the potential clinical benefit in this patient population. During the second quarter, panbrelumab was included in the Pancreatic Cancer Action Network's precision promise, adaptive trial platform, which is evaluating panbrelumab and standard of care for patients with metastatic pancreatic cancer. Moving to Duchenne muscular dystrophy and rome continuous and allelanthus 1 phase 3 trial in non-ambulatory patients, with top-line data now expected in the first half 2023 versus prior guidance of second half 2022. Finally, in idiopathic pulmonary fibrosis, today we're pleased to provide guidance that we expect top-line data from our Cephris 1 phase 3 trial in mid-2023. These timelines assume current COVID conditions, and we will provide further updates as they become available. Moving now to the corporate update, we appointed Dr. John Hunter to the position of Chief Scientific Officer. Moving now to slide 11, in June, we announced our partnership with HiFiBio to advance next-generation therapies for patients with cancer and autoimmune disease, a deal which could enable up to three INDs by 2023. Fibrogen is accessing three new monoclonal antibodies against exciting targets, galactic 9, CXCR5, and CCR8. Galactic 9 is an oncology target with a reported role in acute myeloid leukemia and immune resistance in many solid tumors. Next, CXCR5 is an autoimmune and oncology target, and our primary interest is autoimmunity. But there are also opportunities in better cell lymphomas. Finally, CCR8 is an oncology target with broad potential in solid tumors. Now I would like to provide an update on our internal review. On April 6th, the company clarified the certain previously disclosed cardiovascular safety analysis from the Roxadustat Phase III program for the treatment of anemic and chronic kidney disease included post hoc changes to the stratification factors and provided additional data from the cardiovascular safety analysis with the pre-specified stratification factors. As stated at that time, the company initiated an internal review to ensure this does not occur in the future. We now have completed that review. Key company findings from the review are as follows. The underlying data used for the cardiovascular safety analysis are accurate, with no data integrity issues with the data used to generate such analysis. In its NDA, the company calculated accurately and described both set of analysis. including the statistical methodologies and stratification factors utilized. The statistical analysis using post hoc stratification factors were designated as primary analysis, and the statistical analysis using pre-specified stratification factors as sensitivity analysis. Those responsible for the statistical analysis believed it was a reasonable and valid way to analyze and present the data. Management is taking steps to ensure the company's processes are consistent with best practices in all respects. In addition to other processes and procedures, we plan to implement independent quality unity oversight of clinical data management, programming, analysis, and reporting. Furthermore, those directly responsible for the decision to use post hoc certification factors in the primary analysis no longer work for the company. The use of post hoc stratification factors was not discussed by the FDA Advisory Committee or referenced as a consideration that led to the Advisory Committee vote against recommending approval for Roxas-Dustat. We do not believe that it played any role in that vote. I will now turn the call over to our CFO, Falco Troneo, for the financial update. Pat?