FibroGen, Inc

Good day, and thank you for standing by. Welcome to FibroGen's first quarter 2023 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 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Michael Tong. Please go ahead.

Thank you, Eleanor, and good afternoon, everyone. I'm Michael Tong, Vice President of Corporate Strategy and Investment Relations at Fiverton. 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, Feng Wedig, our Chief Commercial Officer, and Chris Chong, 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 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 Farbergen's filing with the SEC, including our most recent Form 10-K and Form 10-Q. Farbergen 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 FibreGen's website at www.fibregen.com. With that, I would like to turn the call over to Enrique Quintero, our CEO. Enrique?

Very good. Thank you, Mike, and good afternoon, everyone, and welcome to our first quarter 2023 earnings call. On today's call, I'll provide a summary of important accomplishments and development thus far in 2023. Juan Graham, our CFO, will then review the financials, after which we will open the call for your questions. Starting with slide three. Fundragin is positioned to create significant value for patients and shareholders by executing on three areas of focus. delivering pivotal phase III pancreatic data in three high-value indications, idiopathic pulmonary fibrosis, Eugene muscular dystrophy, and locally advanced and resectable pancreatic cancer. Second, increasing our research productivity by advancing novel programs that leverage internal expertise and access external innovation for additional pipeline opportunities. And third, ensuring the commercial success of Roxadustat in patients with chronic kidney disease were approved, while continuing the chemotherapy-induced anemia study in China. Moving on to slide four. Pavergine represents an exciting catalyst-rich opportunity, with top-line data expected from four phase three trials through the third quarter of this year. and an additional two by mid-2024. Operationally, we are well prepared for various clinical trial outcome scenarios, which could include multiple regulatory filings and ultimately launches to expeditiously deliver these therapies to patients. In addition, we are progressing our preclinical pipeline, including potentially filing up to two INDs near year-end 2023. We have taken steps to augment our strong financial position and continue our focus on financial discipline. Moving on to slide five. On May 5th, we announced top-line data from a Matterhorn Phase III clinical study of Roxel Duster for treatment of anemia in patients with transfusion-dependent lower-risk myelodysplastic syndromes, or MDS. To our disappointment, the study did not meet its primary efficacy endpoint. The proportion of patients who achieved red blood cell transfusion independence in the first 28 weeks was 47.5% for the roxodustar arm, compared to 33.3% for placebo, with a p-value of The adverse event profile of Roxadustat that was observed in the preliminary safety analysis was generally consistent with previous findings. Safety will be further evaluated at study completion. Now let's move to our clinical trial timeline from slide 6. Starting at the bottom of slide 6 with Roxadustat, We anticipate top-line data from a China Phase III study in patients with chemotherapy-induced anemia shortly. Moving now to panbrelumab. I want to remind everybody that we have both FDA fast track and FDA orphan disease designations for all three of the indications in Phase III development. Idiopathic pulmonary fibrosis, Duchenne muscular dystrophy, and locally advanced and resectable pancreatic cancer are each diseases with significant unmet medical needs and represent meaningful potential opportunities to improve the lives of patients. Moving chronologically, we expect top-line data from LELANTUS-1, our Phase III trial of pembrelumab in non-ambulatory patients with DMD in the second quarter of 2023, top-line data from Cephras-1, our phase three trial in IPF in mid-2023. Top line data from Allelantis-2 trial in ambulatory patients with DMD in the third quarter of 2023. Looking out to next year, top line data from our Lapis phase three study in locally advanced and resectable pancreatic cancer expected in the first half of 2024. Top line data from our Cephras-2 phase three trial in patients with IPF, which completed enrollment in the first quarter of 2023, is expected mid-2024. Finally, although not on the slide, the Pancreatic Cancer Action Network's Precision Promise Adapted Trial Platform evaluating panbrelumab in combination with standard of care for patients with metastatic pancreatic cancer continues to progress. A common question we receive is whether there's any read-through across the panbreloma 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. LAPC is an oncology indication in which tumor-associated fibrosis is a key feature of the disease. Given these differences in disease pathology, we believe there is limited or no efficacy read through from one of these conditions to another. 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. 2023 will be a transformational year for Fibrojet, and we look forward to sharing the results of these studies. I would like to extend my gratitude to the patients, caregivers, and investigators who 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 panprevlimab, our wholly-owned monoclonal antibody. Slide 7 provides a detailed perspective of the current large and growing IPF commercial opportunity, with a diagnosed prevalence of approximately 330,000 patients across the US, EU, China, and Japan, IPF represents a significant opportunity as the two approved IPF therapies generated together over $4 billion in global net revenue in 2022. Despite the size and growth of the IPF market, there remains important unmet medical need with the approved antifibrotic therapies. which are characterized by continued disease progression and challenging tolerability. There is sentiment in the IPF community of limitations with the current therapies, and we believe Umbrella has the potential to help a sizable number of patients that become a relevant product for the treatment of IPF. As we highlight on slide eight, we believe that IPF patients could benefit from new therapeutic options. IPF is a progressive disease where fibrosis in the lung tissue leads to reversible 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 the challenging total ability profiles. This translates into a low treatment rate, as depicted on the right side of slide eight. In the U.S., 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 a third of these patients are treated with an antifibrotic. 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 photosensitivity. This results in a large proportion of diagnosed U.S. IPF patients not being treated for this progressive and fatal condition. Because of this significant admin need, we believe panbreloma has the potential to be an important addition to current IPF treatment options, including newly diagnosed patients, existing patients who have not been treated with antifibrotics, and those patients who have stopped antifibrotic treatment due to challenging tolerability. I want to reiterate our confidence in the praise results and our optimism on the likelihood of success of our CFRS Phase III program. Moving to slide nine. Both Duchenne muscular dystrophy and locally advanced and resectable pancreatic cancer represent significant opportunities to meaningfully help patients. Beginning with DMD in the left column. Given the devastating nature of DMD and the relentless progression of the disease, we're hopeful that the Lelantus Phase III program can lead to a definitely needed approved therapy. While the currently approved exon skipping therapy produces an increase in dystrophin levels, they target only 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 DMD therapies that can attenuate disease progression by targeting the downstream pathological changes to improve muscle function. We are hopeful the anti-fibrotic mechanism of prambrelumab may be a treatment that can help these patients and their families. The LANTUS-1 enrolled non-ambulatory DMD patients 12 years and older with more advanced disease. The primary endpoint is the performance of the upper limb test, which measures functionality of the shoulder, elbow, wrist, and hand. And we expect top-line data this quarter. The LANTUS-2 enrolled ambulatory DMT patients 6 to 12 years old with less advanced disease. The primary endpoint is the North Star ambulatory assessment, which is a measure of ambulatory function. And we expect top-line data in the third quarter of this year. 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, with a diagnosed prevalence of over 90,000 patients across the major regions combined, and a low five-year disease-free survival rate of approximately 10%. We believe that Panveluma has both direct anti-tumor effects, and effects on the stroma. And this is why we're evaluating both LAPC and 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 commercial opportunity for permvalumab if we can demonstrate a significant improvement in overall survival. We expect top line data from our LAPI study in the first half of 2024. Moving on to slide 10, I do want to take a moment and comment on our early stage pipeline. We expect to file up to two INDs near the end of this year. FG3165 is an anti-Gal9 antibody developed to reverse immune resistance in many solid tumors and inhibit target-driven cancer progression in acute myeloid leukemia, AML. FG3165 has been shown preclinical 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. AFG-3163 is an anti-CCR8 antibody designed to selectively deplete suppressive T regulatory cells in the tumor microenvironment without affecting peripheral T break cells Use of FG3163 in solid tumors has broad potential to activate immune responses and induce tumor cell death without disrupting normal immune homeostasis. In addition, we have undisclosed preclinical development programs, which leverage our expertise in HIF and CTGF biology. Moving to slide 11. Today we announce the FibroGen entry into an exclusive license with Fortis Therapeutics for 446. Fortis' lead drug candidate, 446, represents a potential first-in-class opportunity. This antibody drug conjugate targets a novel epitope on CD46, which is present on certain cancer cells, including prostate, and colorectal cancers, but absent in most normal tissues. 446 is currently in Phase I development for the treatment of metastatic castration-resistant produce cancer and other CD46-expressing cancers. As part of the clinical development strategy, 5GEN will continue to develop a PET-based biomarker utilizing a radiolabeled version of the targeting antibody for patient selection. Under the terms of the agreement, there is no upfront consideration. Fibrogen will conduct and fund future research, development, and manufacturing of 446 and PET46. We have the option to acquire 40s during the four-year evaluation period for $80 million. Moving now to slide 12, Roxadusta continues to grow nicely in China. First quarter, total Roxadusta net sales in China by Fibrogen and the distribution entity jointly owned by Fibrogen and AstraZeneca was $64.1 million, compared to $43.5 million in the first quarter of 2022, an increase of 47%. This growth was driven by an increase in volume of over 50%. Fiverr's portion of Roxadusta net product revenue in China was $24.2 million for the first quarter of 2023 on a U.S. GAAP basis. Juan will provide more detail in the financial update. I will now turn the call over to our CFO, Juan Graham, for this financial update. Juan?