FibroGen, Inc

Good day, and thank you for standing by. And welcome to FibroGen fourth quarter 2021 financial results conference call. At this time, all participants are on a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you'll need to press star 1 on your telephone. Please be advised that this call is being recorded. If you require any further assistance, please press star 0. I would now like to hand the conference over to your host today, Mike Tung, Vice President of Corporate Strategy and Investor Relations. You may begin.

Thank you, Justin. Good afternoon, everyone. I'm Michael Tung, 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, Thane 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 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 about FibroGEN. Such statements may include, but are not limited to, our collaborations with AstraZeneca and Astellas, financial guidance, the 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 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 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 fourth quarter. and a full-year 2021 earnings call. Briefly, before we begin, I would like to highlight that today is Rare Disease Day, which is especially relevant to us given our Panvrelumab Phase III programs and our Roxodustat MDS program. As we enter 2022, we're excited about our future as we continue to advance our Phase III Panvrelumab clinical trials in three indications, continue our strong performance with Roxadustat in China, launch Roxadustat in Europe, and expand our research and development portfolio in the immuno-oncology and autoimmune space. On today's call, I intend to cover recent developments and key events, beginning with Pambrelumab. Juan Graham, our CFO, will then review the financials, after which we will open up the call for your questions. Starting with slide three, Fabergen is 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 need, idiopathic pulmonary fibrosis, locally advanced unreceptable pancreatic cancer, and Duchenne muscular dystrophy. Ensuring commercial success of Roxadustat in patients with chronic kidney disease outside the U.S. while continuing to explore a path forward in the U.S. And number three, increasing our research productivity to advance novel programs that leverage internal expertise and accessing external innovation for additional pipeline opportunities. Let's move to our clinical trials focusing on Pambrello map on slide four. Fandrelumab is a wholly owned asset in Phase III clinical trials for three highly important indications. As we said, IPF, LAPC, and DMD. Today, we announced completion of enrollment of our LAPIS Phase III study of 284 patients with locally advanced and resectable pancreatic cancer. We also completed enrollment of the Relantus-1 Phase III study of 99 patients with non-ambulatory DMD. In the next few weeks, we expect to complete enrollment of the CEPHRS I Phase III study of approximately 340 patients with IPF. Our Phase III CEPHRS study is largely based on our Phase II PRACE study, which demonstrated a meaningful reduction of lung function decline. Each of these diseases represents an important unmet medical need and collectively they constitute a significant market opportunity. We expect multiple Panbrellumab data readouts in 2023 and an interim analysis of LAPC later this year. I'd like to spend a few minutes highlighting our perspective on the significant opportunity we see with Panbrellumab in each of the three disease states, beginning with IPF on slide five. With a diagnosed prevalence of approximately 330,000 patients across the US, EU, China, and Japan, the two key medicines comprising the IPF market generated over $3 billion in net revenue in 2020. Despite this market size, there remains significant unmet need with these two approved therapies, as characterized by continued disease progression and challenging tolerability. There is a sentiment in the IPF community of limitations with the current therapies and a desire for additional therapeutic options. Given the limited number of late-stage products in development, we believe Pumbrello MAP, if approved, is well-positioned to take advantage of this opportunity. If the Phase III CFRS program produces comparable results to the Phase II PRACE trial, we believe Panbreloma has the potential to help a sizable number of patients with IPF and be a very significant product for FibroGen. Turning now to slide six and the locally advanced pancreatic cancer opportunity. Non-metastatic pancreatic cancer represents one of the greatest unmet missing oncology, given the diagnosed prevalence of almost 140,000 patients across the major regions combined with a low five-year disease-free survival rate of around 10%. There have been limited treatment advances in the non-metastatic setting over the last two decades, with therapies failing to demonstrate survival benefits over the current standard of care. Similar to IPF, there's limited late-stage development activity in non-metastatic pancreatic cancer, which creates a meaningful opportunity for panvrelumab if we can demonstrate an improvement in overall survival. As we said earlier, the LAPIS phase three trial is fully enrolled and we look forward to seeing if panvrelumab could provide an important new treatment option for patients. Turning to slide seven. We wrap up the panvrelumab section with a snapshot of the DMD opportunity. Given the devastating nature of DMD and the relentless disease progression, we're hopeful that the LELANTUS clinical trial program can lead to an approved therapy that is so needed by the DMD community. With corticosteroids as the current standard of care, patients commonly deal with troublesome side effects as they continue to experience disease progression and loss of ambulation. While the currently approved exon skipping therapies produce an increased In dystrophin levels, they only target a small proportion of DMD patients. There's clearly need for therapies that can improve muscle function and prolong ambulation by targeting the downstream pathological changes of DMD. We believe the anti-fibrotic mechanism of panbrelumab may be a solution that can help these patients and their families. Now let's move to Roxodustat on slide eight. Following the European Commission approval of Evrenzo for the treatment of adult patients with symptomatic anemia associated with chronic kidney disease, Astellas has launched now in Germany, the United Kingdom, the Netherlands, Austria, and the Nordic countries. The early feedback from healthcare providers prescribing Evrenzo has been positive. The anemia of CKD opportunity in Europe is significant, And Evrenso has an important first-mover advantage relative to other HIV PHIs. Regarding Roxodustine in the US, we and our partner, AstraZeneca, are in discussions on a potential path forward in anemia of CKD. In November, Fabergen and AstraZeneca met with the FDA and discussed next steps following the advisory committee meeting. At this time, we are working together with AstraZeneca to determine those next steps. Moving now to China. As you can see on slide nine, we are reporting total rock-reduced net sales to distributors in China of 32 million for the fourth quarter. The total net rock-reduced sales to distributors in China for 2021 was 186.1 million, significant growth over the 72.5 million in 2020. As a result of the price reduction associated with the NRDL listing renewal, the ROXADUSTA NET sales for the fourth quarter of 2021 reflected a one-time adjustment driven by a revaluation of channel inventory. Fabergen's portion of ROXADUSTA NET product revenue in China was $5.5 million for the fourth quarter and $47.6 million for the full year 2021 on a U.S. GAAP basis. Juan will dive deeper into further detail in the finance updates. We have continued to see broad adoption across the three segments of hemodialysis, peritoneal dialysis, and non-dialysis, and continue to see strong performance of Roxodustad in China. Since the launch of Roxodustad in mid-2019, a primary focus of our commercialization efforts has been to secure hospitalization. which is a right to be prescribed at the particular hospital. As of the end of 2021, we're listed in hospitals that represent approximately 80 percent of the addressable and e-mail CKD market. Roxadustat was included in the 2021 NRDL with a meaningful reduction in price. However, we do expect Roxadustat net sales growth for the full year in China, driven by significant growth in volume. As you can see on slide 10, Roxadusta continues to drive the expansion of the Anemio CKD category and is capturing share in an expanding market. Roxadusta captured the large majority of the category growth for the 12 months ended December 2021 over the same period in 2020. Finally, as shown on slide 11, Roxadusta is the number one branded treatment for anemia of CKD in China for the past 12 months, achieving a value share of 36% in the most recent quarter within that segment that includes all ESA products and Roxadusta currently the only HIF-PHI in the market. 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 patients. I will now turn the call over to our CFO, Juan Graham, for the financial update. Juan.