FibroGen, Inc

Ladies and gentlemen, thank you for standing by and welcome to ViberGen's first quarter 2022 earnings conference call. At this time, all participants' lines are in 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 will need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star 0. I would now like to hand the conference over to your first speaker for today, Michael Tong. Thank you. Please go ahead, sir.

Thank you, RJ, 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 Rico Conterno, our Chief Executive Officer, Dr. Mark Eisner, our Chief Medical Officer, Juan Graham, our Chief Financial Officer, Dr. John Hunter, our Chief Scientific Officer, Feng Wedig, 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 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 Fibersen's filings with the SEC, including our most recent 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. 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 first quarter of 2022 Earnings Call. On today's call, I will provide a high-level summary of the most important accomplishments and developments in the first quarter of 2022. Juan Graham, our CFO, will then review the financials, after which we will open the call for your questions. Starting with slide three, Sovereign 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 needs. Idiopathic pulmonary fibrosis, or IPF, locally advanced and resectable pancreatic cancer, or LAPC, and Duchenne muscular dystrophy, or DMD. Number two, 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. Now let's move to our clinical trials, focusing on Pambrelumab on slide four. Panbrevum is a wholly-owned asset in Phase III clinical trials for three high-value indications, IPF, LAPC, and DMD. Each one of these diseases represents an important unmet medical need, and each constitutes a significant market opportunity. As we recently announced, we have completed enrollment of Arcephalus 1.0, phase 3 study of 356 patients with idiopathic pulmonary fibrosis. The Cephras 1 phase 3 study is largely based on our phase 2 PRESS study, which demonstrated a meaningful reduction in lung function decline. Enrollment continues in our second Cephras phase 3 study. This is Cephras 2, and we look forward to updating you as that trial progresses. We completed enrollment of the LELANTUS-1 phase three clinical trial of panvrelumab in non-ambulatory patients with Duchenne muscular dystrophy, DMD, in the first quarter, and expect to complete enrollment of the LELANTUS-2 phase three clinical trial of panvrelumab in ambulatory patients with DMD in the second quarter. It is very exciting to be expecting data readouts for LELANTUS-1, 2, and Cephras I in 2023. And I want to thank our clinical development team for their efforts. Moving now to locally advanced pancreatic cancer. As discussed previously, we plan an interim analysis of event-free survival in the second quarter. Depending on the results and in consultation with the FDA, we will decide whether to file for accelerated approval. After making this decision, we will provide an update later this year. Regardless, the trial will continue to the primary endpoint of overall survival, and we expect top-line data in the first half of 2024. I'd now like to spend a few minutes highlighting our perspective on the significant commercial opportunity we see with PanreluMap in each of the three disease areas. on slide five, beginning with IPF. With a diagnosed prevalence of approximately 330,000 patients across the US, EU, China, and Japan, IPF represents a significant opportunity with the two approved IPF therapies generating almost $4 billion in net revenue in 2021. 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. If the Phase III CFRS program produces similar results to the Phase II PRACE trial, We believe panbrelumar has the potential to help a sizable number of patients with IPF and be a very significant product for FibroTen. In the middle column, you can see the locally advanced pancreatic cancer opportunity. Pancreatic cancer represents one of the greatest unmet needs in 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 the immune oncology therapies failing to demonstrate survival benefits over the current standard of care. Similar to IPF, there is limited late-stage development activity in non-metastatic pancreatic cancer, which creates a meaningful opportunity for panbrelumab if it 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 panbrelumab could provide an important new treatment option. And finally, in the third column, we wrap up the panbrelumab market section with a snapshot of the DMD opportunity. While the prevalence of DMD is the lowest of the three indications we're pursuing, given the devastating nature of his diagnosis 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 current approved exon skipping therapies produce an increase in dystrophin levels, they are targeted at a small portion of DND patients and have yet to demonstrate a meaningful clinical improvement in symptoms or disease progression. There's a clear need for therapies that can improve muscle function and prolong ablation by targeting the downstream pathological changes of DMD. We believe the anti-fibrotic mechanism of Convreluma may be a solution that can help these patients and their families. Now let's move to Roxadustan on slide six. Following the European Commission approval of Evrenzo for the treatment of adult patients with symptomatic anemia associated with chronic kidney disease. Astellas has launched in Germany, the UK, Netherlands, Austria, and Nordic countries. While uptake has been slower than expected, the early feedback from healthcare providers prescribing Evrenzo has been positive. The anemia of CKD opportunity in Europe is significant. and Renzo has an important first-mover advantage relative to other HIF PHIs. Launches will commence in the other major EU markets later this year, pending positive reimbursement decisions. Despite significant discussions with AstraZeneca, we have not been able to find a path forward for AstraZeneca to fund further Ruxandustra development of anemia of CKD in the U.S., We continue to believe Roxadustat can address an admin need for patients with CKD anemia. It's important to note that we continue development of Roxadustat in MDS with top line phase three data expected in the first half of 2023. Moving now to China. Roxadustat was renewed in the NRDL for another two years beginning January 2022. As expected, this relisting was accompanied with a price reduction. As you can see on slide seven, we are reporting first quarter total Roxodustan Nelsos in China of $43.5 million by Fibrogen and the joint distribution entity, which is flat compared to the first quarter of 2021. This was driven by a greater than 70% increase in volume offset by the recent NRDL price reduction. We expect Roxadustat NEO sales growth for the full year in China, driven by significant growth in volume. FibroGems portion of Roxadustat NEO product revenue in China was $18.9 million for the first quarter on a U.S. GAAP basis. Juan will dive into further details in the finance update. Turning now to updated external market data on slide eight, Roxadusta continues to be the number one branded treatment for anemia CKD as measured by values shared in the category, which includes all ESA products on Roxadusta. We expect this category leadership to continue as Roxadusta volume continues to grow at a fast pace. Next, slide nine provides a snapshot of Roxadusta unit growth as indexed to December 2020 on the chart on the left, as well as year-over-year growth in the table on the right. Of note is the consistent unique growth of Roxas-Dustat while the leading ESA brand is slightly up, reflecting the anemia CKD market expansion that has been driven by Roxas-Dustat since its original NRDA listing in 2020. Now, it is worth taking a minute to comment on the COVID situation in China. As you are aware, lockdowns have been implemented to reduce the spread of COVID in a number of cities, including Shanghai and Beijing. Thus far, we have not seen an impact on Ruxatusta demand in China. Where we have seen an impact is in some of our clinical trial enrollment in China. We are and we will continue to monitor the situation closely closely as it evolves, and our thoughts are with our China employees during this difficult time. I will now turn the call over to our CFO, Juan Graham, for the financial update. Juan? Thank you, Enrique.