FibroGen, Inc

Good day and thank you for standing by. Welcome to the Fiverr Gents second 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 1-1 on your telephone. You will 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 your speaker today, Michael Tong. Please go ahead.

Thank you, Bella, and good afternoon, everyone. I'm Michael Tong, Vice President of Corporate Strategy and Investor Relations at Fiverrgin. 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, Thayne Wettig, 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 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 FiberGEN'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 statement, whether as a result of new information, future events, or otherwise. The press release reporting our financial results and business update in 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?

Very good. Thank you, Mike, and good afternoon, everyone, and welcome to our second 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 second 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. Fibrogen 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, or IPF. Locally advanced and resectable pancreatic cancer, or LAPC. and Duchenne muscular dystrophy, or DMD. Number two, ensuring commercial success of Rosodusta 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, beginning with pembrelumab on slide four. Pembrelumab is a wholly owned asset in phase three clinical trials for three high-value indications, IPF, LAPC, and DND. Each one of these diseases represents an important unmet medical need, and each constitutes a significant market opportunity. As we recently announced, During the second quarter, we completed an enrollment of the LELANTIS-2 Phase III clinical trial of pembrelumab in ambulatory patients with DMV. This brings the number of fully enrolled pivotal pembrelumab trials to four, the Cephras-1 trial in IPF, the LELANTIS-1 and LELANTIS-2 trials in non-ambulatory and ambulatory DMV, respectively, and the LAPIS trial in LAPC. Enrollment continues in our second Cephris Phase III study in IPF, and we look forward to updating you as the trial progresses. Moving now to locally advanced pancreatic cancer. As previously discussed, we set a very high bar for event-free survival that would have enabled us to file for accelerated approval. An independent interim analysis of event-free survival in the LAPIS Phase III study was conducted in the second quarter. Based on the interim analysis, we will not be filing a BLA for accelerated approval. As planned, the study will continue to its primary endpoint of overall survival with top-line data expected in the first half of 2024. It is very exciting to be expecting data readouts from four pivotal Phase III trials in 2023. the Cephras-1 phase III trial in IPF mid-2023, the Lelantus-1 and Lelantus-2 phase III trials in DMD in the first half of 2023 and the second half of 2023, respectively, and the Matterhorn phase III trial of Roxadustat in MDS in the first half of 2023. I'd now like to spend a few minutes highlighting our perspective on the significant commercial opportunity we see with panbrelumab in each of the three disease areas on slide five, beginning with IPF. With a diagnosed prevalence of approximately 330,000 patients across the U.S., 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 correlability. There is sentiment in the IPF community of limitation with the current therapies and a desire for additional therapeutic options. In the Phase III Cephras program produces similar 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 medicine for 5G. In the middle column, you can see 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%. 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 limited late-stage development activity in non-metastatic pancreatic cancer, which creates a meaningful commercial opportunity for Panvelma in LAPC if it can demonstrate a significant improvement in overall survival. In addition, the pancreatic cancer action network's precision PROMIS adaptive trial platform, evaluating panbreloin in combination with standard of care for patients with metastatic pancreatic cancer continues to progress. And finally, in the third column, we wrap up the panbreloin market section with a snapshot of the DMV opportunity. 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 an approved therapy that is desperately needed by the DMD community. While the currently approved exon skipping therapies produce an increase in the dystrophin levels, they are targeted at a small proportion of DMD patients. 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 anti-fibrotic mechanism of Panbreluma may be a solution that can help these patients and their families. Now let's move to Roxadustat on slide six. Roxadustat continues to be approved in additional countries and was recently approved in Mexico and South Africa. It is now approved in China, Europe, Japan, and numerous other countries for the treatment of CKD patients on dialysis and non-dialysis. Evrenso has an important first-mover advantage in the EU relative to other HIF-PHIs, and Astellas recently received positive reimbursement decisions in the UK, Finland, Slovakia, and Sweden. We believe the anemia of CKD opportunity in Europe is significant. And while initial uptake has been slower than expected in the EU countries where Avrenso has launched, the early feedback from healthcare providers prescribing Avrenso has been positive. As noted earlier, we continue development of Roxodustat in MBS with the partners AstraZeneca and Astellas. And moving now to China, Roxadusta continues its strong performance. As you can see on slide seven, we are reporting second quarter total Roxadusta net sales in China of $53.1 million by Fibrogen and the Joint Distribution Entity, compared to $52.8 million in the second quarter of 2021. This was driven by an increase of over 80% in volume offset benefiting from the price reduction of the NRDL. We continue to expect Roksodusta net sales growth for the full year in China driven by significant growth in volume. Fibergen's proportion of Roksodusta net product revenue in China was $23.3 million for the second quarter on a U.S. GAAP basis. Juan will elaborate further in the financial update. Turning now to the updated external market data on slide eight. Broxibustat continues to be the number one branded treatment for an EMEOS CKD as measured by the value shared in the category which includes all ESA products on Broxibustat. We split this category leadership to continue, as Roxadustat volume continues to grow at a fast pace. Next, slide 9 provides a snapshot of Roxadustat 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 a significant unit growth of Roxadustat, while the leading ESI brand is slightly up, reflecting the anemia of CKD market expansion that has been driven by Roxas-Bustam since its original energy leasing in 2020. I will now turn the call over to our CFO, Juan Graham, for the financial update. Juan?