FibroGen, Inc

Thank you for standing by, and welcome to FibroGen's fourth quarter and full year 2022 financial results earnings 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 1-1 on your telephone. I would now like to hand the call over to your host, Mike Tung.

Please go ahead. Thank you, Lateef, 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 Rika 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, and 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 a 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 Fibrogen's 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 Farberton's website at www.farberton.com. Now, 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 fourth quarter and full year 2022 earnings call. On today's call, I intend to provide a high-level summary of important accomplishments and developments for 2022 and recent months. Juan Graham, our CFO, will then review the financials, after which we will open the call for your questions. Starting with slide three, Fabergen is positioned to create significant value for patients and shareholders by executing on three areas of focus. Number one, delivering Pivotal Phase III panbrelumab data in three high-value indications, idiopathic pulmonary fibrosis, Duchenne muscular dystrophy, and locally advanced and resectable pancreatic cancer. Number two, increasing our research productivity by advancing novel programs that leverage internal expertise and access external innovation for additional pipeline opportunities. Number three, ensuring the commercial success of Roxodustat in patients with chronic kidney disease were approved. We'll continue to explore additional indications. Moving on to slide four. Farbigen represents an exciting catalyst-rich opportunity. Top line data for five PIVOTO phase three trials are expected this year. and an additional two by mid-2024. In 2022, we completed enrollment of multiple clinical trials for both Panbrevlimab and Roxadustat, and our progress showcases our capability to deliver on our clinical trial goals and advance our pipeline. We are preparing for various clinical trial outcome scenarios, which could include multiple regulatory filings and ultimately launches, to expeditiously deliver these potential therapies to patients. Operationally, we were prepared to execute our plan. And importantly, we have a strong financial position and a continued focus on financial discipline with a wide array of options to consider as we look for opportunities to strengthen our cash position over time. Now let's move to our clinical trial timelines on slide five, starting with pembrelumab. I want to remind everyone that we have both FDA fast track and FDA orphan disease designations for all three of these indications. Idiopathic pulmonary fibrosis, or IPF, Duchenne muscular dystrophy, or DMD, and locally advanced and resectable pancreatic cancer, or LAPC, are each diseases with significant unmet medical need and represent meaningful potential opportunities to improve the lives of patients. Moving chronologically, we expect top-line data from LELANTOS-1, our phase three trial of pembrelumab in non-ambulatory patients with DMD in the second quarter of 2023. Top-line data from Cephros-1, our phase three trial in IPF in mid-2023. Data from our LELANTIS-2 trial in ambulatory patients with DMD in the third quarter of 2023. Now looking out to next year, our LAPIS phase three study in locally advanced pancreatic cancer is expected to read out in the first half of 2024. And finally, our Cephros-2 phase three trial in patients with APF is expected to report out mid-2024. In addition, although not on the slide, The Pancreatic Cancer Action Network's PANCAM Precision Promise adaptive trial platform evaluating panbrevlimab in combination with standard of care for patients with metastatic pancreatic cancer continues to progress. A common question we receive is whether there is any read-through between the panbrevlimab trials. IPF DMD and LAPC are three very different diseases, all with a common feature of fibrosis, but each with a unique pathophysiology affecting different organs. In IPF, fibrosis in the lung tissue causes progressive and irreversible damage. DMD is a rare genetic pediatric disease characterized by fibrosis in the muscles. An LAPC is an oncology indication in which tumor-associated fibrosis is a key feature of the disease. Given these differences in disease pathophysiology, we believe there's limited or no read-through on efficacy from one of these conditions to the others. On the safety side, panbreluma has been studied in over 1,000 patients and has demonstrated a favorable adverse event and safety profile, including in patients who have been dosed for up to seven years. Moving to the Roxadusta timelines, on the bottom of slide five, we anticipate readouts from the Matterhorn phase three trial in patients with anemia or myelodysplastic syndromes in the second quarter of 2023, and data from our China phase three study in patients with chemotherapy-induced anemia expected in the second quarter of 2023 as well. This will be a transformational year for Fabergen, and we look forward to sharing the results of these studies. I would like to extend my gratitude to patients, caregivers, and investigators, as well as to my Fabergen colleagues for their commitment. I'd now like to spend a few minutes highlighting our view of the significant commercial opportunity we see with Panbrevlimab, our wholly-owned monoclonal antibody. Starting on slide six, I will be providing a more detailed perspective on our view of the IPF opportunity than in past calls. 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 together almost $4 billion in global net revenue in 2021. Despite the size and growth of the IPF market, there remains an important unmet need with the two approved antifibrotic therapies as characterized by continued disease progression and challenging tolerability. There's a sentiment in the IPF community of limitations with the current therapies, and we believe pembrelumab has the potential to help a sizable number of patients and become a relevant product for the treatment of IPF. As we highlight on slide seven, we believe that IPF patients could benefit from new therapeutic options. IPF is a progressive disease. where fibrosis in the lung tissue leads to irreversible loss of lung function, resulting in high morbidity and mortality. In fact, median survival following diagnosis of IPF is only three to five years. The limitations of current treatment options are well characterized, having a modest effect on slowing the progressive loss of lung function along with a challenging tolerability profile. This translates into a low treatment rate, as depicted on the right side of slide seven. In the US, there is a prevalence of approximately 120,000 patients with IPF, with approximately 30,000 patients diagnosed each year. Of these 30,000 newly diagnosed patients, we estimate that only about one third of these patients are treated with an antifibrotic. And of these roughly 10,000 patients that start one of the two approved antifibrotics in a given year, approximately 40% to 50% discontinued treatment in the first 12 months usually due to side effects, which include severe nausea, diarrhea, and fossil sensitivity, resulting in a large proportion of diagnosed US IPF patients not being treated with standard of care for this progressive and deadly condition. Because of this significant unmet need, we believe Pembrelumab has the potential to be an important addition to current IPF treatment options, competing effectively for newly diagnosed patients, for existing patients who have not been treated with antifibrotics, and as well as those patients who have stopped antifibrotic treatment due to challenging tolerability. Moving on to slide eight, Duchenne muscular dystrophy and locally advanced and receptive pancreatic cancer each represent significant opportunities. Starting with DMD in the left column, given the devastating nature of DMD and the relentless progression of the disease, we are hopeful that the Lantus Phase III program can lead to an approved therapy that is desperately needed by the DMD community. While the currently approved exon skipping therapies produce an increase in dystrophin levels, they target only a small portion of DMD patients and have yet to demonstrate a meaningful clinical improvement in symptoms or disease progression. There's clear need for DMD therapies that can attenuate disease progression by targeting the downstream pathological changes to improve muscle function and prolong ambulation. We're hopeful The antifibrotic mechanism of Pambrelva may be a treatment that can help these patients and their families. Lelanthus 1 enrolled non-ambulatory patients 12 years and older with more advanced DMD disease. The primary endpoint is the performance of upper limb tests, which measure functionality of the shoulder, elbow, wrist, and hand. Lelanthus 2 enrolled ambulatory patients 6 to 12 years old with less advanced DMD disease. The primary endpoint is the North Star ambulatory assessment, which is a measure of ambulatory function. In the right-hand column, we show a snapshot of the locally advanced pancreatic cancer opportunity. 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%. We believe that pembrelumab has both direct anti-tumor effects and effects on the stroma. This is why we're evaluating both LAPC as well as metastatic pancreatic cancer. There have been limited treatment advances over the last two decades, with immune oncology therapies failing to demonstrate survival benefits over the current standard of care. This creates a potential meaningful opportunity for panvrelumab if we can demonstrate a significant improvement in overall survival. Now let's move to the update on Roxodustat on slide nine. Roxodustat is currently in phase three clinical trials for the treatment of anemia in myelodysplastic syndromes, MDS, in the US and Europe. and for the treatment of patients with chemotherapy-induced anemia, or CIA in China. Starting with myelodysplastic syndromes, or MDS, MDS are a group of rare blood disorders that occur because of abnormal development of blood cells within the bone marrow. It is estimated that more than 10,000 patients are diagnosed with MDS each year in the U.S., And overall prevalence is estimated to be between 60,000 and 170,000 patients in the US. Anemia is a major complication present in 85% of patients with MBS when first diagnosed and causes fatigue, shortness of breath, dizziness, and weakness, and over time can lead to frequent red blood cell transfusions. More recently, Luspatercept was approved in this indication, and its successful launch illustrates the unmet medical need. We expect top-line data from our global phase III Matterhorn MDS trial in the second quarter of 2023. Finally, we also expect top-line data from our China phase III chemotherapy induced anemia trial in the second quarter of 2023. Moving on to slide 10, I do want to take a moment and comment on an early stage pipeline. We expect to file up to two INDs in the second half of 2023. FG3165 is an anti-GAL9 antibody developed to reverse immune resistance in many solid tumors and inhibit target-driven cancer progression in AML, acute myeloid leukemia. FG3165 has been shown preclinically to prevent GAL9-mediated cell death of T-cell subtypes that are critical for anti-tumor immune responses, and is undergoing characterization for its ability to directly target leukemic cell populations. is an anti-TCR8 antibody designed to select clivate suppressive T regulatory cells in the tumor microenvironment without affecting peripheral T regulatory cells. Use of FG3163 in solid tumors has broad potential to activate immune responses and induce tumor cell killing without disrupting normally immune homeostasis. Additionally, we have undisclosed preclinical development programs that leverage our expertise in HIF and CTGF biology. And moving now to China on slide 11, Roxadusta continues its robust growth in China. We are reporting fourth quarter total Roxadusta nail cells in China of $53.1 million by Fabergen. Joint Distribution Entity, compared to $32 million in the fourth quarter of 2021. This growth was driven by an increase in volume of over 90%. Roxadustadnesso's growth for full year 2022 in China was $22.7 million, which was driven by an increase in volume of over 80%. Fabrikant's portion of Roxadusta net product revenue in China was $23.4 million for the fourth quarter and $82.9 million for the full year 2022 on a U.S. GAAP basis. Juan will elaborate further in the financial update. Next, on slide 12. Slide 12 provides a snapshot of Roxadusta Juni 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 a significant unit growth of Roxadustat, while the leading ESA brand is up slightly, reflecting the anemia of CKD market expansion that has been driven by Roxadustat since its original un-RDL listing in 2020. I'm going to now turn the call over to our CFO, Juan Graham, for the financial update. Thank you, Enrique.