FibroGen, Inc

Hello, thank you for standing by and welcome to the FibroGen third quarter 2021 financial results conference call. At this time, all participants are in a listen-only mode. After the speaker 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 hand the conference over to your speaker today, Dr. Michael Tong. Please go ahead.

Thank you, Josh. Good afternoon, everyone, and welcome to FibreGen's 2021 Third 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, Dr. Mark Eisner, our Chief Medical Officer, Juan Graham, our Chief Financial Officer, Dr. John Hunter, our Chief Scientific Officer, Fain Wedick, our Chief Commercial Officer, and Chris Chung, our Senior Vice President of China Operations. The format for today's call will include prepared remarks from Enrique and Juan, 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 based on Fibrogen's current expectations. Such statements may include statements regarding, 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 cause actual results to differ materially from those anticipated in such statements. For discussion of these and other material risk 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 third quarter financial results and business update, our most recent forms 10K and 10Q, and reports that we may file on form 8K with the Securities and Exchange Commissions. All our statements are made as of today, November 9th, 2021, based on information currently available to us. And Fibrogen 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 third quarter financial results and business update in a webcast of today's conference call can be found on the investor section of Fibrogen's website at www.fibrogen.com. And with that, I would like to turn the call over to Enrique Quintero, our CEO. Enrique?

Very good. Thank you, Mike. Good afternoon, everyone, and welcome to our third quarter 2021 earnings call. Today, I would like to provide a high-level summary of important accomplishments and developments in recent months. I would also like to welcome and introduce our newly appointed CFO, Juan Graham, who will review the financials. We will then open the call for your questions. I also want to thank Pat Cotronell, who stepped down as CFO in September and who worked at Fibrogen for 21 years. Under his leadership, Fibrogen transitioned from a private to public company and from a development stage to commercial stage company. Pat will serve as executive advisor through March 2022 to ensure a smooth transition. Today's call will include an update of the regulatory status of Roxodustat and our continuous strong performance in China. So why don't we get started? Let's get started with Roxodustat on slide three. In August, the European Commission approved Evrenzo for the treatment of symptomatic anemia associated with chronic kidney disease. Astellas? has launched in Germany, the United Kingdom, Netherlands, and Austria. And yearly feedback from healthcare providers is positive. The anemia of CKD opportunity in Europe is significant, and Evrenso has an important first-mover advantage relative to other HPHIs. The recent FDA complete response letter we received for Oxetustat for the treatment of Anemia of chronic kidney disease, however, represents a major setback. We and our partner, AstraZeneca, are in discussions on a potential path forward in anemia of CKD, and we have an additional meeting with the FDA scheduled. In China, we reported another strong quarter of Roxazusta performance. Finally, last week, We and our partners, Astellas and AstraZeneca, presented 15 poster presentations related to Roxadustat and CKD at the ASN Kidney Week 2021 virtual conference. Moving now to slide four and the recent reorganization. Given the uncertainty regarding Roxadustat's path forward in the U.S., we have developed and are beginning the implementation of a comprehensive plan which includes a cost reduction effort that would enable us to focus on our strategic priorities of development of Pambrelu map, Roxadusta, and advancing our pipeline. Our plan is to reduce projected expenses by approximately $100 million per year for each of the next three years. We are eliminating approximately 100 positions in the U.S., of which 70% are open positions and 30% are existing positions. We thank all the employees whose positions were eliminated for their meaningful contributions to Fibrogen. Moving to slide five, Fibrogen continues to be positioned to create significant value for patients and shareholders by executing on our three areas of focus. Number one, accelerating the development of pembrelumab in three indications with significant unmet medical needs. Idiopathic pulmonary fibrosis, locally advanced and resectable pancreatic cancer, and Duchenne muscular dystrophy. Number two, ensuring commercial success of Roxadustan in patients with chronic kidney disease outside the U.S., while exploring a path in the U.S. and with a potential for expansion into additional therapeutic indications. Number three, increasing our research productivity to advance novel programs that leverage internal expertise and accessing external innovation for additional pipeline opportunities. As you can see on slide six, were pleased to report total Roxadustat net sales to distributors in China of $57.8 million for the third quarter and $154.1 million year-to-date for 2021. We continue to see increased Roxadustat adoption. Fabrigem reported $13.4 million in China Roxadustat net product revenue for the third quarter 2021 and 42.2 million year-to-date. 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 eight 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 and is capturing share in an expanding market. Roxadustat captured 74% of the category growth for the eight months ended August 2021 over the same period in 2020. Finally, as shown on slide nine, Roxadustat is the number one branded treatment for anemia of CKD in China for the past eight months, achieving a value share of 33% in the most recent month within the segment that includes all ESA products on Roxadustat, currently the only HIEF PHI on the market. By year end, we expect to finalize the revised reimbursement price for Roxadustat in China, which will be lower, and are prepared to ensure continued growth year on year. 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 programs on slide 10. Today, we are reiterating our timelines reported last quarter. And we continue to make progress on the licensed HIFI biotherapeutic assets, and to evaluate the other program opportunities available under the exclusive option agreement. I will now turn the call over to our CFO, Juan Graham, for the financial update. Juan?