FibroGen, Inc

Good day, and thank you for standing by. Welcome to FibroGen's third quarter 2022 earnings call. At this time, all participants 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 one one on your telephone. You'll then hear an automated message advising your hand is raised. Please be advised that today's conference is being recorded. I would now like to hand the conference over to today's speaker, Michael Tung, Vice President of Corporate Strategy and Investor Relations. The floor is yours.

Thank you, Gerald, and good afternoon, everyone. I'm Michael Tung, Vice President of Corporate Strategy and Investor Relations at FibreGen. Joining me on today's call are Rika 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 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 the call for your 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 preferences filings with the SEC, including our most recent Form 10-K and Form 10-Q. FibreGen 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 on financial results and 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. And 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 third quarter 2022 earnings call. On today's call, I will provide a high-level summary of the most important accomplishments and developments in the third 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, today we announced a royalty monetization transaction with NovaQuest Capital Management, securing $50 million of additional non-dilutive capital, strengthening our balance sheet. We will use the additional proceeds to continue to support our strategic priorities, advancing our late-stage development programs, where we anticipate top-line data from seven pivotal Phase III studies, beginning in the first half of 2023 through mid-2024, five from PAMBREBLUMAP and two from ROXADUSTAT. as well as progressing our early stage pipeline. You can read more about the transaction in a press release published earlier today. Moving to slide four. Fibrogen is positioned to create significant value for patients and shareholders by executing on our three areas of focus. Number one, delivering pivotal phase three PAMBREVA data in three indications with significant unmet medical needs. idiopathic pulmonary fibrosis, or IPF, Duchenne muscular dystrophy, or DMD, and locally advanced unresectable pancreatic cancer, or LAPC. Number two, ensuring the commercial success of Roxadustat in patients with chronic kidney disease outside the U.S., as well as delivering phase three data in myelodysplastic syndromes, MDS, and chemotherapy-induced anemia, or CIA. Number three, increasing our research productivity to advance novel programs that leverage internal expertise and access external innovation for additional pipeline opportunities. Let's move to our clinical trials on slide five. Throughout 2022, we have made significant progress in enrolling our phase three studies. It's very exciting to be anticipating data readouts from seven pivotal phase three trials starting in the first half of 2023 through mid-2024. Let's begin with pembrelumab. Data from LELANTOS-1, our phase three trial of pembrelumab in non-ambulatory patients with DMD is expected in the first half of 2023. The Cephras-1 phase three trial of pembrelumab in patients with IPF is expected to read out in mid-2023. Data from Arlelantus-2 trial of pembrelumab in ambulatory patients is expected in the second half of 2023. Arlelapis phase three study of pembrelumab in locally advanced pancreatic cancer patients is expected to read out in the first half of 2024. And finally, we are pleased to announce today that our Cephris-2 phase three trial of pembrelumab in patients with APF is expected to report out mid-2024. Moving to the Roxadustat program, we anticipate readouts from the Matterhorn phase 3 trial of Roxadustat in patients with anemia of myelodysplastic syndromes in the first half of 2023, and data from our China phase 3 study of Roxadustat in patients with chemotherapy-induced anemia expected in mid-2023. 2023 will be a transformational year for Fabrigan, and we look forward to sharing the results of these studies. I would like to extend my gratitude to the patients, caregivers, and investigators, as well as my far-reaching colleagues for their commitment to these studies. I'd now like to spend a few minutes highlighting our perspective on the significant potential commercial opportunity we see with PAMBRELU-MAP, our wholly-owned monoclonal antibody program in each of the three disease areas on slide six, 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. Important to note, there remains significant admin 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. We believe Pambrelumab has the potential to help a sizable number of patients with IPF and be a very relevant medicine for patients. In the middle column, you can see the DMV opportunity. given the devastating nature of DMD and the relentless progression of the disease, we're hopeful that the Lantus Phase III program can lead to an approved therapy that is desperately needed by the DMD community. While the current approved exon skipping therapies produce an increase in the dystrophin levels, they're targeted at a small proportion of DMD patients and have yet to demonstrate a meaningful clinical improvement in symptoms or disease progression. There is a clear need for therapies that can attenuate disease progression by targeting the downstream pathological changes to improve muscle function and prolong ambulation. We believe the antifibrotic mechanism of pembrelumab may be a solution that can help these patients. And finally, in the third column, we wrap up with a snapshot of the locally advanced pancreatic cancer opportunities. Pancreatic cancer represents one of the largest unmet needs in oncology, given the diagnosed prevalence of over 90,000 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 immune oncology therapies failing to demonstrate survival benefits over the current standard of care. There is also limited late-stage development activity in non-metastatic pancreatic cancer, which creates a meaningful commercial opportunity for pembrelumab in LAPC if we can demonstrate a significant improvement in overall survival. In addition, the Pancreatic Cancer Action Network's precision PROMIS adaptive trial platform evaluating pembrelumab in combination with standard of care for patients with metastatic pancreatic cancer continues to progress. Now let's move to Roxadustat on slide seven. We continue the ongoing Roxadustat clinical trials for the treatment of anemia and myelodysplastic syndromes, or MDS, in the US and Europe, and for the treatment of patients with chemotherapy-induced anemia, or CIA, in China. Roxadustat is approved in China Europe, Japan, and numerous other countries for the treatment of anemia in chronic kidney disease patients. The European commercial activity with Roxadustar is accelerating, as it was recently launched in the United Kingdom, Germany, the Netherlands, and the Nordic countries, with further launches expected in the major EU markets over the coming months. We believe the anemia of CKD opportunity in Europe is significant. And while initial uptake has been slower than expected, where Evrenso has launched, the early feedback from healthcare providers prescribing Evrenso has been quite positive. And moving to China, Roxadusta continues its strong performance, as you can see on slide eight. We are reporting third quarter total Roxadusta net sales in China of $59 million by Fibrogen and the Joint Distribution Entity. compared to $57.8 billion in the third quarter of 2021. This represents an increase of 2% in U.S. dollars, despite the price reduction to the NRDL renegotiation and the impact of currency. This growth was driven by an increase in volume of over 80%. We continue to expect Roque d'Houston Air Sales growth for the full year 2022 in China, driven by significant growth in volume. Favreger's portion of Roxadusta net product revenue in China was $17.4 million for the third quarter on a U.S. GAAP basis. Juan will elaborate further in the finance update. Turning now to the updated external market data on slide 9. Bruxa d'Usta continues to be the number one branded treatment for Anemio CKD as measured by value share in the category, which includes all ESA products and Bruxa d'Usta. We expect this category leadership to continue as Bruxa d'Usta volume continues to grow at a fast pace. Next, slide 10 provides a snapshot of Bruxa d'Usta JuniGrowth 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 significant unit growth of Roxadustat, where the leading ESA brand is slightly up, reflecting the Anemio CKD market expansion that has been driven by Roxadustat since its original NRDO listing in 2020. I will now turn the call over to our CFO, Juan Graham, for the financial update. Juan?