Q1 2024 FibroGen Inc Earnings Call

May 6, 2024

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Operator: Good day, and thank you for standing by. Welcome to FibroGen's first quarter 2024 earnings conference call. At this time, all participants are in a listen-only mode.

Speaker Change: Good day, and thank you for standing by and welcome to the five regions first quarter 2024 earnings Conference call. At this time all participants are in a listen only mode. After the speaker's presentation there'll be a question and answer session to ask a question. During this session. Please press star one one on your telephone.

Speaker Change: For your name to be announced to withdraw your question. Please press star. One again, please be advised that today's conference is being recorded I would now like to hand, the conference over to your speaker today, David <unk>.

Operator: After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, please press star-one-one on your telephone and wait for your name to be announced. To withdraw your question, please press star-one-one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, David DeLucia, Vice President, Investor Relations.

David: Vice President Investor Relations.

David DeLucia: Thank you for joining us today to discuss our first quarter 2024 financial and business results. I'm David DeLucia, Vice President of Corporate FP&A and Investor Relations at FibroGen. Joining me on today's call are Thane Wettig, our Chief Executive Officer, Dr. Deyaa Adib, our Chief Medical Officer, Juan Graham, our Chief Financial Officer, Dr. John Hunter, our Chief Scientific Officer, and Chris Chung, our Senior Vice President of China Operations. Following our prepared remarks, we will open the call to your questions.

David: Good afternoon, everyone. Thank you for joining us today to discuss our first quarter 2024 financial and business results I'm, David de La <unk>, Vice President of corporate SG&A and Investor Relations at fiber Jim <unk>.

Speaker Change: Joining me on today's call are saying why they are chief Executive Officer, Dr. Dan <unk>, Our Chief Medical Officer, One Graham our Chief Financial Officer, Dr. John Hunter, Our Chief Scientific Officer, and Chris Chung, Our senior Vice President of China operations.

Speaker Change: Following our prepared remarks, we will open the call to your questions I would like to remind you that remarks made on today's call include forward looking statements about fiber Jim.

David DeLucia: 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 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.

Speaker Change: 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.

Speaker Change: 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.

Speaker Change: In that statement.

Speaker Change: More complete description of these and other material risks can be found in fiber jumped filings with the SEC, including our most recent Form 10-K and Form 10-Q fiber.

Speaker Change: <unk> 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 investors section of <unk> website at Www Dot fiber Gen Dot com.

David DeLucia: 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 in the Investors section of FibroGen's website at www.fibrogen.com. With that, I'd like to turn the call over to our CEO, Thane Wettig. Thank you, Dave.

Saying Works: With that I'd like to turn the call over to our CEO, saying works.

Thane Wettig: Good afternoon, everyone, and welcome to our first quarter 2024 earnings call. On today's call, I will focus our stakeholders on the four strategic pillars shaping our company's future trajectory. Additionally, I'll offer insights into the progress of our Pam Revlimab and Roxadustat programs. Dr. Deyaa Adib, our chief medical officer, will review the top line data from our CD46 targeted antibody drug conjugate, FG3246, in metastatic castration-resistant prostate cancer and articulate why we feel so strongly about our recently released phase one top line results. And Juan Graham, our CFO, will review the financials, after which we will open the call to your questions.

Saying Works: Thank you Dave Good afternoon, everyone and welcome to our first quarter 2024 earnings call on today's call I will focus our stakeholders on the four strategic pillars shaping our company's future trajectory. Additionally, I'll offer insights into the progress of our <unk> and <unk> programs Dr.

Speaker Change: <unk>, our Chief Medical Officer will review the topline data from our CD 46 targeted antibody drug conjugate fg's $32 46 in metastatic castration resistant prostate cancer and articulate why we feel so strongly about our recently released phase one topline results and one gram our CFO.

Speaker Change: <unk> will review the financials after which we will open the call for your questions.

Thane Wettig: Starting on slide three, FibroGen has four key strategic pillars that we believe offer significant value today. The first is Pam Revlimab, where we are preparing for readouts from two pivotal phase three studies in pancreatic cancer. In the coming months, we plan on releasing top-line data from Precision Promise, the Pancreatic Cancer Action Network's Phase 2-3 Adaptive Platform trial for metastatic pancreatic cancer, and from our ongoing LAPIS Phase 3 trial in locally advanced pancreatic cancer.

Speaker Change: Starting on slide three <unk> has four key strategic pillars that we believe offer significant value today.

Speaker Change: First is <unk>, where we are preparing for readouts from two pivotal phase III studies in pancreatic cancer in the coming months, we plan on releasing top line data from precision promise pancreatic cancer action networks phase two three adaptive platform trial for metastatic pancreatic cancer and from our ongoing <unk>.

LAPIS phase III trial in locally advanced pancreatic cancer.

Thane Wettig: Pancreatic cancer is a disease with substantial unmet clinical need and represents a significant commercial opportunity for Pamrevimab, which has demonstrated an effect in both preclinical and early clinical studies in pancreatic cancer, and which we will detail in a moment. Second, there is Roxadustat.

Speaker Change: Pancreatic cancer is a disease with substantial unmet clinical need and represents a significant commercial opportunity for <unk>, which has demonstrated an effect in both preclinical and early clinical studies in pancreatic cancer, and which we will detail in a moment.

Thane Wettig: Roxadustat is approved in over 40 countries, generates significant net revenue and positive cash flow, and provides FibroGen with material and growing economics through our partnerships with AstraZeneca and Astellas Pharma. We're expecting an approval decision from the Chinese authorities in the second half of 2024 for chemotherapy-induced anemia, which, if approved, would represent meaningful revenue growth on top of the substantial revenue generated by Roxidustat for anemia FibroGen has regained the rights to Roxas DUSAT from AstraZeneca in the U.S. and ROW territories, excluding China and South Korea.

Speaker Change: Second is <unk> <unk> is approved in over 40 countries generates a significant net revenue and positive cash flow and provides fiber jen with material and growing economics through our partnerships with Astrazeneca and Astellas pharma.

Speaker Change: We're expecting an approval decision from the China authorities in the second half of 2024 for chemotherapy induced anemia, which if approved would represent meaningful revenue growth on top of the substantial revenue generated by <unk> in anemia associated with chronic kidney disease.

Speaker Change: By region has regained the rights to <unk> from Astrazeneca in the U S and <unk> territories, excluding China and South Korea.

Thane Wettig: This allows us the opportunity to potentially partner Roxasustat in certain indications with high-end met needs, such as anemia in patients with lower risk myodysplastic syndrome. Third, we have an early stage oncology pipeline. We are very excited about the potential of these programs.

Speaker Change: This allows us the opportunity to potentially partner <unk> in certain indications with high unmet needs such as anemia in patients with lower risk Myelodysplastic syndromes.

Speaker Change: Third is our early stage oncology pipeline, we are very excited about the potential of these programs.

Thane Wettig: FG3246 is a first-in-class potent antibody drug conjugate, or ADC, targeting CD46 for the treatment of metastatic castration-resistant prostate cancer and potentially other solid tumors. This program also includes the development of an associated CD46-targeted pet biomarker. In April, we released compelling data from our FG3246 Phase 1 monotherapy trial, which Deyaa will go into later on the call. In addition to FG-3246, we have recently submitted an IND for FG-3165, our antigelectin-9 monoclonal antibody, and await FDA clearance of the application.

Speaker Change: FG 30 to 46 is a first in class potent antibody drug conjugate or ADC targeting CD 46 for the treatment of metastatic castration resistant prostate cancer and potentially other solid tumors.

Speaker Change: This program also includes the development of an associated CD 46 targeted pet biomarker.

Speaker Change: In April we released compelling data from our <unk> $32 46 phase one monotherapy trial, which Dale will go into later on the call and.

Speaker Change: In addition to FG $32 46, we have recently submitted an IND for FG $31 65, our anti collected nine monoclonal antibody and await FDA clearance of the application.

Thane Wettig: We are also planning to file an IND for FG3175, our anti-CCR8 monoclonal antibody, in 2025. The fourth pillar is our strong cash position. We finished the quarter with approximately $214.7 million in cash, cash equivalents, investments, and accounts receivable.

Speaker Change: We are also planning to final on IND for F. G 31, 75, our anti <unk>, our <unk> monoclonal antibody in 2025.

Speaker Change: The fourth pillar is our strong cash position, we finished the quarter with approximately $214 $7 million in cash cash equivalents investments and accounts receivable, we expect our strong balance sheet to be sufficient to fund our operating plans into 2026.

Thane Wettig: We expect our strong balance sheet to be sufficient to fund our operating plans into 2026. In summary, we believe there are few biotechnology companies of our market cap that have such a compelling mix of commercial, late-stage, and early-stage assets. When you combine our assets, our strong balance sheet, and the quality of our talented colleagues at FibroGen, we believe that we have a strong foundation to drive significant shareholder value creation today and into the future.

Speaker Change: In summary, we believe there are a few biotechnology companies of our market cap that have such a compelling mix of commercial late stage and early stage assets. When you combine our assets our strong balance sheet and the quality of our talented colleagues of fibers and we believe that we have a strong foundation to drive significant shareholder value creation today.

Speaker Change: And into the future.

Thane Wettig: Moving to slide 5, Pamrevelumab is a novel anti-CTGF human monoclonal antibody in clinical development for the treatment of metastatic pancreatic cancer and locally advanced unresectable pancreatic cancer, or LAPC. Pam Revlimab has demonstrated dose and exposure-related responses in an early stage pancreatic cancer trial and, having been studied in over 1,000 patients across various conditions, a favorable safety and tolerability profile. I would now like to discuss the PamrevoMap opportunity in pancreatic cancer in more detail, starting on slide 6.

Speaker Change: Moving to slide five <unk> is a novel anti TGF human monoclonal antibody in clinical development for the treatment of metastatic pancreatic cancer and locally advanced unresectable pancreatic cancer or <unk>.

Speaker Change: <unk> has demonstrated dose and exposure related responses in an early stage pancreatic cancer trial and having been studied in over 1000 patients across various conditions.

Speaker Change: Favorable safety and Tolerability profile.

Speaker Change: I would now like to discuss the <unk> opportunity in pancreatic cancer in more detail starting on slide six.

Thane Wettig: Pancreatic cancer represents one of the largest unmet needs in oncology with an annual incidence of nearly half a million patients across the major regions combined. This includes approximately 60,000 PDAC patients in the U.S. Additionally, there is an overall five-year disease-free survival rate of only 12.5 percent.

Speaker Change: Pancreatic cancer represents one of the largest unmet needs in oncology with an annual incidence of nearly half a million patients across the major regions combined.

Speaker Change: This includes approximately 60000 pediatric patients in the U S.

Speaker Change: There is an overall five year disease free survival rate of only 12, 5% and for metastatic cancer. The survival rate is approximately 3%. Unfortunately, there have not been any major therapeutic advances for quite some time.

Thane Wettig: And for metastatic cancer, the survival rate is approximately 3 percent. Unfortunately, there have not been any major therapeutic advances for quite some time. On slide 7, we provide an overview as to why we believe PanrevoMap can provide benefits to patients diagnosed with pancreatic cancer. Based on preclinical data, connective tissue growth factor, or CTGF, plays an important role in the growth and progression of pancreatic tumors.

Speaker Change: On slide seven we provide an overview as to why we believe <unk> can provide benefits to patients diagnosed with pancreatic cancer.

Speaker Change: Based on preclinical data connective tissue growth factor or CTG App plays an important role in the growth and progression of pancreatic tumors.

Thane Wettig: Mouse pancreatic tumor studies have shown that Pamrevimab, by inhibiting the biological activity of CTGF, can have both direct anti-tumor effects and effects on the surrounding stroma, providing a strong clinical rationale for use in both locally advanced and metastatic pancreatic cancer. Moving to slide eight. We would like to reference the data from our Open Label Dose Escalation Phase 1-2 Trial in patients with locally advanced stage 3 or metastatic stage 4 pancreatic cancer.

Speaker Change: Mouse pancreatic tumor studies have shown that Pam rebel map by inhibiting the biological activity of CTG can.

Speaker Change: You can have both direct anti tumor effects and effects on the surrounding stroma, providing a strong clinical rationale for use in both locally advanced and metastatic pancreatic cancer.

Speaker Change: Moving to slide eight.

Thane Wettig: Almost 90% of these 75 patients were in fact metastatic, with only 9 having locally advanced disease. Pamrevlimab was evaluated in combination with gemcitabine and erlotinib as first-line therapy. An important observation in the study was that enhanced clinical benefit was observed at higher drug exposure levels. Once drug plasma levels reached a trough threshold of 150 micrograms per mL, a number of important results were found.

Speaker Change: We would like to reference the data from our open label dose escalation phase one two trial in patients with locally advanced stage III or metastatic stage four pancreatic cancer almost 90% of these 75 patients were in fact metastatic with only nine having locally advanced disease.

Speaker Change: <unk> was evaluated in combination with gem side have been and are lot nib as first line therapy.

Speaker Change: An important observation in this study was it enhanced clinical benefit was observed at higher drug exposure levels.

Speaker Change: Once drug plasma levels reached a trough threshold of 150 micrograms per ml a number of important results were found.

Thane Wettig: The most notable result in this study was that one-year survival was 37% for patients who had circulating PAM-Revlimab levels of 150 micrograms per ml or higher versus 11% for those with lower plasma levels. These results in the higher exposure cohort patients also included improved median overall survival and improved median progression-free survival. Moving to slide 9, in late January, we announced the completion of the PAMREVOMAB arm and Precision Promise Pancreatic Cancer Action Network Space 2-3 Adaptive Platform Trial for Metastatic Pancreatic Cancer, which evaluates PamrevoMab in combination with the chemotherapy treatments gemcitabine and nabpaclitaxel for patients with metastatic pancreatic ductal adenocarcinoma.

Speaker Change: The most notable result in this study was that one year survival was 37% for patients who had circulating <unk> levels of 150 micrograms per ml or higher versus 11% for those with lower plasma levels.

Speaker Change: These results from the higher exposure cohort patients also included improved median overall survival and improved median progression free survival.

Speaker Change: Moving to slide nine in late January we announced the completion of the <unk> precision promise pancreatic cancer action that workspace to three adaptive platform trial for metastatic pancreatic cancer, which evaluates <unk> in combination with the chemotherapy treatments Gemcitabine and Nab Paclitaxel.

Speaker Change: For patients with metastatic pancreatic ductal adenocarcinoma.

Thane Wettig: The PRECISION PROMISE trial is a Phase 2, 3 registrational study that is being executed at the top pancreatic cancer centers in the United States. The primary endpoint of the trial is overall survival. In this study, Pamrevelumab is being evaluated in both first and second line metastatic disease.

Speaker Change: The precision promise trial as a phase two three Registrational study that is being executed at the top pancreatic cancer centers in the United States.

The primary endpoint of the trial is overall survival in this study <unk> is being evaluated in both first and second line metastatic disease.

Thane Wettig: Slide 10 provides additional details on the Precision Promise Study, which is comprised of two stages. In the initial stage of the study, or stage 1, 100 patients with metastatic pancreatic cancer received Tamrevlimab in combination with gemcitabine and nabpaclitaxin. Guided by Bayesian principles, the graduation threshold for PAMREVIMAB was a protocol-specified greater than or equal to 35% predictive probability of success for the primary endpoint of overall survival at the completion of the trial.

Speaker Change: Slide 10 provides additional details on the precision promise study, which is comprised of two stages in.

Speaker Change: In the initial stage of the study or stage, one 100 patients with metastatic pancreatic cancer receive <unk> in combination with gem side of being in Nab Paclitaxel.

Speaker Change: Guided by Bayesian principles congratulation threshold for <unk> was a protocol pre specified greater than or equal to 35% predictive probability of success for the primary endpoint of <unk>.

Overall survival at the completion of the trial.

Thane Wettig: The PAMREVIMAB arm successfully graduated to Stage 2 in the third quarter of 2022, and an additional 75 patients were enrolled, receiving the same PAMREVIMAB treatment regimen as in Stage 1. All patients were dosed until disease progression, and the final analysis is based on the data collected for all patients up to 12 months after the last patient initiated treatment, including patients enrolled during the analysis period between stages one and two. A total of 213 patients participated in the PAMREVIMAB arm of the study.

Speaker Change: The <unk> arm successfully graduated to stage two in the third quarter of 2022, and an additional 75 patients were enrolled.

Speaker Change: <unk> the same Pam rebel mab treatment regimen as in stage one.

All patients were dosed until disease progression and the final analysis is based upon the data collected for all patients up to 12 months after the last patient initiated treatment.

Speaker Change: Including patients enrolled during the analysis period between stages, one and two.

Speaker Change: Total of 213 patients participated in the <unk> arm of the study.

Thane Wettig: The PAMREVIMAB arm of the PRECISION PROMISE trial was completed in late January of this year. PAMREVIMAB is the first experimental arm of the PRECISION PROMISE trial to meet its pre-specified threshold for graduation to Stage 2, and we now expect to report top-line data in mid-2024, reflecting PAMCAN's updated timing to complete database lock and subsequent analysis of the top-line results by the Independent Statistical Monitoring Committee On slide 11, we provide an overview of the Global Phase 3 LAPIS trial.

Speaker Change: The <unk> arm of the precision promise trial was completed in late January of this year.

Speaker Change: <unk> is the first experiment alarm in the precision promise trial to meet its prespecified threshold for graduations in stage, two and we now expect to report topline data in mid 2024.

Speaker Change: Reflecting pan cancer updated timing to complete database lock and subsequent analysis of the topline results by the independent Statistical monitoring Committee.

Speaker Change: On slide 11, we provide an overview of the global phase III LAPIS trial.

Thane Wettig: A double-blind, placebo-controlled trial in 284 patients with locally-advanced, unresectable pancreatic cancer comparing Pamrevelmab to placebo in combination with standard-of-care chemotherapy. The primary endpoint is overall survival. Given LAPIS is an event-driven trial, we continually monitor the number and trend of events to ensure we have the most up-to-date perspective on when the trial will accrue the required number of events and allow us to lock the database.

Speaker Change: A double blind placebo controlled trial in 284 patients with locally advanced Unresectable pancreatic cancer, comparing <unk> to placebo in combination with standard of care chemotherapy.

Speaker Change: The primary endpoint is overall survival.

Speaker Change: Given LAPIS is an event driven trial, we continually monitor the number and trend of events to ensure we have the most up to date perspective on when the trial will accrue the required number of events and allow us to lock the database.

Thane Wettig: Since our last update, the pace of events has decreased, which is a common occurrence in this type of oncology study. We now expect top-line data from the LAPIS Phase III study of pancrevelmab and locally-advanced unresectable pancreatic cancer in the third quarter of 2024, reflecting the current number and trend of overall survival events. Moving to slide 12, we show a snapshot of the 2-pound Revlimib registrational studies which are being conducted in locally advanced and metastatic patients.

Speaker Change: Since our last update the pace of events has decreased which is a common occurrence in this type of oncology study.

Now expect top line data from the LAPIS Phase III study of <unk> in locally advanced Unresectable pancreatic cancer in the third quarter of 2024, reflecting the current number and trend of overall survival events.

Speaker Change: Moving to slide 12, we show a snapshot of the <unk> Registrational studies, which are being conducted in locally advanced and metastatic patients.

Thane Wettig: These patients represent almost 90% of all diagnosed pancreatic cancer patients today, giving PamrevoMed the potential opportunity to treat a vast majority of patients with this devastating disease. One important difference between the two studies is the dosing regimen of the Precision Promise study. Pemrevimab is dosed in 28-day treatment cycles until disease progression or discontinuation, which is distinct from lapis in which PamrevoMab was delivered in a neoadjuvant setting and where it was dosed for up to six months.

Speaker Change: These patients represent almost 90% of all diagnosed pancreatic cancer patients today, given <unk> the potential opportunity to treat a vast majority of patients across this devastating disease.

Speaker Change: One important difference between the two studies is the dosing regimen of the precision promise study.

Speaker Change: <unk> is dosed in 28 day treatment cycles until disease progression or discontinuation wishes.

Speaker Change: Which is distinct from LAPIS in which <unk> was delivered in the neo adjuvant setting and where it was dosed for up to six months.

Thane Wettig: We believe the ability to dose patients until disease progression in a metastatic setting provides a potential opportunity to amplify clinically meaningful increases in overall survival driven by those patients benefiting from Pemrevo Meb treatment. On slide 13, we review the U.S. commercial opportunity for PamrevoMab in pancreatic cancer. There have been limited treatment advances over the last two decades in both locally advanced and metastatic diseases, with immuno-oncology therapies providing benefit to a small subset of metastatic patients.

Speaker Change: We believe the ability to dose patients until disease progression in the metastatic setting provides a potential opportunity to amplify clinically meaningful increases in overall survival driven by those patients benefiting from <unk> treatment.

Speaker Change: On Slide 13, we review the U S commercial opportunity for <unk> in pancreatic cancer, there had been limited treatment advances over the last two decades in both locally advanced and metastatic diseases with immuno oncology therapies, providing benefit to a small subset of metastatic patients.

Thane Wettig: Using straightforward assumptions, the total addressable market for pancreatic cancer in the U.S. represents a multi-billion dollar opportunity for pemrevimab if it can demonstrate a clinically meaningful improvement in overall survival in either locally advanced or metastatic patients. Even modest penetration in either of these segments represents a substantial commercial opportunity in the U.S. alone, where FibroGen plans to commercialize Pemeverm on its own should it receive game approval.

Speaker Change: Using straightforward assumptions the total addressable market for pancreatic cancer in the U S represents a multibillion dollar opportunity for Perm rebel Mab, if it can demonstrate a clinically meaningful improvement in overall survival in either locally advanced or metastatic patients each.

Speaker Change: Even modest penetration in either of these segments represents a substantial commercial opportunity in the U S alone.

Speaker Change: We're fibrogenesis plans to commercialize on its own Triphammer perm ever Mab game approval.

Thane Wettig: In summary, Pemrevomab, if approved, could represent a meaningful advance in prolonging survival for patients with pancreatic cancer and a game-changing opportunity for FibroGen. We expect top-line results in the near term.

In summary, <unk>, if approved could represent a meaningful advance in prolonging survival for patients with pancreatic cancer and a game changing opportunity for fiber Jen we expect topline results in the near term.

Speaker Change: Moving now to slide 15.

Thane Wettig: Roxasducet for anemia of chronic kidney disease continues to perform extremely well in China. First quarter total RoxyGestat net sales in China by FibroGen and the distribution entity jointly owned by FibroGen and AstraZeneca were $79.4 million, compared to $64.1 million in the first quarter of 2023, an increase of 24%. This growth was driven by an increase in volume of 39%.

Speaker Change: <unk> for anemia of chronic kidney disease continues to perform extremely well in China.

Speaker Change: First quarter total <unk> reduced that net sales in China by <unk> and the distribution entity jointly owned by fiber <unk> and Astrazeneca.

Speaker Change: $79 4 million.

Speaker Change: Compared to $64 1 million in the first quarter of 2023.

Speaker Change: An increase of 24% this growth was driven by an increase in volume of 39%.

Thane Wettig: FibroGen's portion of Roxadustat net product revenue in China was $30.5 million for the first quarter on a U.S. GAAP basis, compared to $24.2 million in the first quarter of 2023, an increase of 26%. Moving to slide 16, Rochester-Du-State continues to expand its category leadership and brand value share in China, rising to 47% in the most recent three-month period ending in February of 2024. The potential addition of the chemotherapy-induced anemia indication would provide an important new treatment alternative for patients with chemotherapy-induced anemia and would be a meaningful addition to the ROXADUCE business in China.

Speaker Change: The <unk> portion of <unk> net product revenue in China was $35 million for the first quarter on a U S GAAP basis.

Speaker Change: Compared to $24 $2 million in the first quarter of 2023, an increase of 26%.

Speaker Change: Moving to slide 16 rocks reduce debt continues to expand its category leadership and brand value share in China rising to 47% in the most recent three month period ending in February of 2024.

Speaker Change: The potential addition of the chemotherapy induced anemia indication would provide an important new treatment alternative for patients with chemotherapy induced anemia and be a meaningful addition to the <unk> business in China.

Speaker Change: Given that there have been several generic applications filed in China, I would like to reiterate the dynamics of the generic market more broadly in China and the exclusive exclusivity of <unk>.

Speaker Change: The impact of a generic approval and launch in China is meaningfully different than in the U S market.

Thane Wettig: Generic players face lead time and execution risk of market adoption after approval as they need to be admitted into hospital formularies one listing at a time. However, originator products do not experience a meaningful deterioration in revenue until at least four generic products are approved. Even then, originator products in China have historically been able to maintain a stream of net revenues and profits after generics enter the market. Thus, despite the expiration of our Composition of Matter patents in June 2024, we do not expect meaningful deterioration of the ROC's two-step business in the near term. In addition to the continued outstanding performance of Roxa Ducet in China, Rock seduced penetration in Europe continues to increase, showing strong quarter over quarter growth.

Speaker Change: Generic players face lead time and execution risk of market adoption after approval as I need to be admitted into hospital formularies, one listing at a time.

Speaker Change: Originated products do not experience a meaningful deterioration in revenue until at least four generic products are approved.

Speaker Change: Even then originator products in China have historically been able to maintain a stream of net revenues and profits after generics enter the market.

Speaker Change: Despite the exploration of our composition of matter patents in June 2024.

Speaker Change: We do not expect meaningful deterioration of the rocks just that business in the near term.

Speaker Change: In addition to the continued outstanding performance of <unk> in China <unk>.

Speaker Change: <unk> penetration in Europe continues to increase showing strong quarter over quarter growth.

Thane Wettig: We expect this growth to continue given the fact that Roxadustat is now fully reimbursed in all EU5 countries. Roxasucea is the only HIF-PHI indicated in the EU for the treatment of anemia of CKD in both non-dialysis and dialysis patients. And with GSK's decision to withdraw the MAA for Dapr-Dustat, RoxyDustat maintains its strong competitive position in the EU.

Speaker Change: We expect this growth to continue given the fact that <unk> is now fully reimbursed in all EU five countries.

Speaker Change: <unk> is the only hit PHA indicated in the EU for the treatment of anemia of <unk> in both non dialysis and dialysis patients.

Speaker Change: And with Gsk's decision to withdraw the MAA for that produced at <unk> that maintains its strong competitive position in the EU.

Thane Wettig: Of note, we have recently been successful in defending RoxyDustat's patent portfolio, and now believe RoxyDustat has exclusivity into 2036, positioning it to continue its growth and hip market leadership over the next decade in the EU. Moving to slide 17, earlier in the year, we announced that AstraZeneca returned all U.S. ROW rights for Roxasustat to FibroGen, with the exception of South Korea. FibroGen's collaboration agreement with AstraZeneca for Roxasustat in China remains in place.

Speaker Change: Of note we have recently been successful in defending <unk> patent portfolio and now believe <unk> has exclusivity into 2036 position and positioning it to continue its growth and hip market leadership over the next decade in the EU.

Speaker Change: Moving to slide 17 earlier in the year, we announced that Astrazeneca returned all U S RW rights.

Speaker Change: For Roxanne just at two five region with the exception of South Korea, <unk> collaboration agreement with Astrazeneca for <unk> in China remains in place.

Thane Wettig: Regaining the rights to Roxasducet in the U.S. allows us to pursue Roxasducet development opportunities with potential partners in indications such as anemia associated with lower risk myodysplastic syndrome. On slide 18, we highlight the potential opportunity for Roxidustat in patients with anemia associated with lower risk MDS. There is a well-defined patient population and a clear clinical need given the current therapeutic alternatives, which translates into a significant commercial opportunity. We continue outreach to potential interested parties.

Speaker Change: Regaining the rights trucks do set in the U S allows us to pursue <unk> development opportunities with potential partners in indications such as anemia associated with lower risk lower risk Myelodysplastic syndrome.

Speaker Change: On slide 18, we highlight the potential opportunity for <unk> in patients with anemia associated with lower risk Mds, there's a well defined patient population and a clear clinical need given the current therapeutic alternatives, which translates into a significant commercial opportunity we continue outreach to potential interested.

Speaker Change: Parties.

Thane Wettig: Moving on to slide 19, late last year, we presented data from the Phase 3 Matterhorn Study of rocks used in patients with anemia of lower risk myotisplastic syndrome at the American Society of Hematology annual meeting. Although we missed the primary endpoint of transfusion independence driven by a high placebo response in patients with low transfusion burden at baseline. Roxidustat demonstrated a numerical advantage relative to placebo. When looking specifically at results in patients with a higher transfusion burden at baseline, there was a statistically significant and clinically meaningful advantage in transfusion independence in patients treated with Roxidustat versus placebo.

Speaker Change: Moving on to Slide 19 late last year, we presented data from the phase III Matterhorn study <unk> in patients with anemia of lower risk Myelodysplastic syndrome at the American Society of Hematology annual meeting.

Speaker Change: Although we missed the primary endpoint of transfusion independence, driven by a high placebo response in patients with low transfusion burden at baseline.

Speaker Change: <unk> demonstrated a numerical advantage relative to placebo when looking specifically at results in patients with a higher transfusion burden at baseline there was a statistically significant and clinically meaningful advantage and transfusion independence in patients treated with <unk> versus placebo.

Thane Wettig: Based on these results, we continue to believe that Roxiducet represents an important potential therapy for patients in the U.S. and other territories where it has not yet been approved. Finally, in April, we announced compelling top-line results from our Phase 1 monotherapy study of FG3246 in patients with metastatic castration-resistant prostate cancer. Before I hand it over to Deyaa Adib, our new CMO, I would like to highlight the deep clinical development experience that Deyaa brings to FibroGen.

Speaker Change: Based on these results we continue to believe that <unk> represents an important potential therapy for patients in the U S and other territories, where it has not yet been approved.

Speaker Change: Lastly in April we announced compelling top line results from our phase one monotherapy study of FG $32 46 in patients with metastatic castration resistant prostate cancer.

Thane Wettig: He has over 28 years of biopharmaceutical drug development experience, including multiple global product submissions, approvals, and launches. Most importantly, Deyaa advances our capabilities in both pancreatic cancer and prostate cancer, given his prior experience, and we are fortunate to have him leading the clinical development team. Deyaa, over to you.

Speaker Change: Before I hand, it over to Dave <unk>, our new CMO I would like to highlight the deep clinical development experience that <unk> brings to fiber Jen.

Speaker Change: He has over 28 years of Biopharma drug development experience, including multiple global product submissions approvals and launches.

Speaker Change: Most importantly, the advances our capabilities in both pancreatic cancer and prostate cancer given his prior experiences and we are fortunate to have him leading the clinical development team.

Dave: Over to you.

Deyaa Adib: Before I begin, I would first like to thank all of you for joining us today. I'm delighted to be part of the team here at FibroGen. I've been here for just over two months now, and I'm very excited about the prospects of the company's innovative oncology pipeline. Moving to slide 21, FG3246 is a first-in-class ADC for metastatic castration-resistant prostate cancer, colorectal cancer, and other tumor types. FG3246 binds to a cell receptor target that internalizes upon antibody binding and is present in approximately 50 to 70 percent of prostate tumors.

Speaker Change: Thank you.

Speaker Change: Again I would firstly.

Speaker Change: I'm delighted to be part of the team here at <unk>.

Yes.

Speaker Change: I've been here for just over two months now.

Speaker Change: And I'm very excited about the prospects of the company's innovative oncology pipeline.

Deyaa Adib: But that demonstrates a very limited expression in most normal tissues, making it an ideal ADC target candidate. FG3246 is comprised of an anti-CD46 antibody, YS5, linked to an anti-mitotic agent, MMAE, which is a clinically validated and FDA-approved ADC payload. On slide 22, we show that FG3246 has demonstrated efficacy against CD46-expressing tumors in both preclinical and clinical studies, and Associated PET Imaging Biomarker, PET46, utilizes the same targeting antibody as FG3246 and is under clinical development at UCSF. It is composed of the YS5 antibody coupled to the radionuclide zirconium 89 and, in preclinical studies, demonstrates specific targeting of and uptake by CD46 positive tumor cells.

Speaker Change: Moving to slide 21, <unk> hundred 46 is a pressing class ADC.

Speaker Change: For metastatic castration resistant prostate cancer colorectal cancer and other tumor types.

Speaker Change: <unk> $32 46 binds to a cell receptor target.

Speaker Change: That internalizes upon antibody binding and is present in approximately 50% to 70% of prostate tumors, but that demonstrates the very limited expression in most normal tissue, making it an ideal ADC target candidate.

Speaker Change: <unk> hundred 46 is comprised of an any CD 46 antibody <unk> five linked to an anti mitotic agent MMA, which is clinically validated and FDA approved ADC payloads.

Speaker Change: On slide 22, we show that <unk> $32 46 has demonstrated efficacy against CD 46, expressing tumors in both preclinical and clinical studies.

Speaker Change: And associated pet imaging biomarker, but 46.

Speaker Change: Utilizes the same targeting antibody FG $32 46, and is under clinical development at UCSF.

Speaker Change: It is constituted of the wireless five antibody coupled to the radionuclide zirconium 89 and in preclinical studies demonstrate specific targeting.

Speaker Change: And uptake by CD 46 positive tumor cells.

Speaker Change: FG three 246 has demonstrated monotherapy clinical efficacy in metastatic castration resistant prostate cancer.

Deyaa Adib: In the dose expansion arm of the trial, patients were treated at 2.7 mg per kg, adjusted body weight dosing to 100 kg, until disease progression or the occurrence of toxicity, for example, those limiting toxicity. The endpoints were safety, tolerability, and anti-tumor activity as measured by the decline of prostate specific antigen from baseline, objective tumor response rate in patients with measurable disease, and radiographic progression-free survival using the prostate cancer working group criteria for tumor response assessment.

Deyaa Adib: The completed phase one trial included a total of 56 peristaltic castration-resistant prostate cancer patients who were biomarker unselected and received a median of five prior lines of therapy before receiving FG3246. In the efficacy analysis population, we observed a median radiographic progression-free survival of 8.7 months. For Resist Evaluable Patients, 20% met the criteria of a partial response, or tumor reduction in size of at least 30% compared to baseline, with a median duration of response of 7.5 months. Additionally, PSA reductions of at least 50% were observed in 36% of patients.

Speaker Change: Now, let's get into the top line results from the monotherapy phase one trial.

Speaker Change: In MCR PUC on slide 23.

Speaker Change: In the phase one dose escalation component of the study.

Speaker Change: Those levels of FG three to 46 were administered in 21 day cycles.

Speaker Change: In the dose expansion arm of the trial patients were treated at $2 seven milligram per kg adjusted body weight dosing to 100 kilogram until disease progression or occurrence of toxicity for example dose limiting toxicities.

Speaker Change: Endpoints, where safety tolerability and anti tumor activity as measured by the decline of prostate specific antigen from baseline objective tumor response rate in patients with measurable disease, and radiographic progression free survival using the prostate cancer working group criteria for.

Speaker Change: Tumor response assessment.

Speaker Change: Okay.

Speaker Change: The completed phase one trial includes a total of 56 metastatic castration resistant prostate cancer patients.

Speaker Change: Who are the biomarker unselected and received immediate five prior lines of therapy before receiving FG 30 to 46.

Speaker Change: And the efficacy analysis population, we observed immediate geographic progression free survival of eight seven months.

Speaker Change: Resist evaluable patients, 20% met the criteria of a partial response or tumor reduction in size of at least 30% compared to baseline.

Speaker Change: With a median duration of response of seven five months.

Speaker Change: PSA reductions.

Speaker Change: At least 50% were observed in 36% of patients.

Deyaa Adib: FG3246 demonstrated an acceptable safety profile with adverse events consistent with those observed in other antibody drug conjugate therapies with an MMAE payload. We look forward to publishing the totality of the Phase I data in a manuscript in the coming months as we advance the program further into the clinic. We are encouraged by these findings, and we believe a radiographic progression-free survival of 8.7 months is very compelling compared with existing standards of care in MCRPC settings.

Speaker Change: <unk> hundred 46 demonstrated an acceptable safety profile with adverse events consistent with those observed in other anti body drug conjugate therapies within MMA payloads.

We look forward to publishing the totality of the phase one data in a manuscript in the coming months as we advance the program further into the clinic we.

Speaker Change: We are encouraged by these findings and we believe it adds geographic progression free survival of eight seven months is very compelling versus existing standards of care in <unk> setting.

Deyaa Adib: We believe that radiographic PFS is a mature, clinically meaningful endpoint versus other early signals such as PSA 50 and objective response rate. Other early stage data in the same space have only shown results for PSA-30 and PSA-50 as signals of clinical activity in a limited number of patients but have not yet shown survival data, which constitutes clinically meaningful endpoints in metastatic castration-resistant prostate cancer. Moving to slide 24.

Speaker Change: We believe that radiographic PFS isn't mature clinically meaningful endpoints versus other early signals such as PSA 50, and objective response rate.

Speaker Change: Other early stage data in the same space has only shown results for PSA 30 in PSA 50 as signals of clinical activity in a limited number of patients, but have not yet shown survival data, which constitutes clinically meaningful endpoints in metastatic castration resistant.

Speaker Change: Safe cancer.

Moving to slide 24.

Deyaa Adib: There is also a combination trial with enzalutamide that is currently being run at UCSF. The rationale for this combination is based on preclinical data demonstrating upregulation of CD46 in tumor cells post-exposure to a second-generation Anderson receptor signaling inhibitor, therefore potentially sensitizing them to treatment with FG3246. I'm excited to remind everyone that we announced that interim data from the dose-escalation portion of the study for FG3246 in combination with enzalutamide was selected for poster presentation at the 2024 American Society of Clinical Oncology annual meeting on June 2nd.

Speaker Change: There is also a combination trial with <unk>.

Speaker Change: That is currently being drawn at UCSF.

Speaker Change: I shall now for this combination is based on preclinical data demonstrating upregulation of <unk> 46 in tumor cells.

Speaker Change: Most exposure to a second generation androgen receptor signaling inhibitor, therefore, potentially sensitizing them to treatment with FG 30 to 46 I'm excited to remind everyone.

Speaker Change: That we announced that interim data from the dose escalation portion of the study.

Speaker Change: For FG $32 46 in combination with <unk> was selected for poster presentation at the 2020 for American Society of clinical oncology annual meeting on June 2nd.

Deyaa Adib: Also, a trial for the PET46 biomarker in prostate cancer is in progress at UCSF. The goal is to develop a screening assay to be able to select patients with high CD46 expression who are most likely to benefit from treatment with FG3246.

Speaker Change: Also at trial for the past 46 biomarker in prostate cancer is in progress at UCSF. The goal is to develop a screening assay to be able to select patients with high <unk> 46 expression, who are most likely to benefit from the treatment with FG three $2 46.

Deyaa Adib: The radiopharmaceutical biomarker will be part of our phase two dose optimization monotherapy trial sponsored by FibroGen. This could potentially enhance screening, patient selection, and enrichment, ensuring the proper selection of patients for the target to receive therapy and derive meaningful clinical benefits. Lastly, we are planning a meeting with the FDA in the third quarter to discuss the details of the FG3246 development program. Contingent upon reaching agreement with the FDA on the trial design, we anticipate the initiation of a phase two, three dose optimization and registration enabling study in metastatic castration-resistant prostate cancer in the fourth quarter of 2024. Finally, moving to slide 25.

Speaker Change: The radiopharmaceutical biomarker will be part of our phase two dose optimization mono therapy trial sponsored by fiber Jen.

Speaker Change: This could potentially enhanced screening patient selection and enrichment, ensuring the proper selection of patients for the target to receive therapy and drive meaningful clinical benefits. Lastly, we are planning a meeting with FDA in the third quarter to discuss the details of the <unk>.

Speaker Change: 246 development program contingent.

Speaker Change: Contingent upon reaching agreement with the FDA on the trial design.

Speaker Change: We anticipate the initiation of a phase III dose optimization and registration, enabling study in metastatic castration resistant prostate cancer in the fourth quarter of 2024.

Speaker Change: Finally, moving to slide 25.

Deyaa Adib: We want to summarize the unique opportunity that FG3246 presents. FG3246 represents a novel mechanism of action and a first-in-class opportunity pairing an antibody against a novel target with a validated chemotherapy payload. FG3246, they offer treatment beyond prostate cancer, with potential applications in multiple lines of metastatic castration-resistant prostate cancer in combination with enzalutamide and other solid tumors such as colorectal cancer. FG3246 could potentially represent a paradigm shift in oncology, offering not only a novel mechanism of action but also promising efficacy, safety, and potential across various cancers. We look forward to updating you on FG32 I will now turn the call over to Juan to discuss the company's financials.

Speaker Change: We want to summarize the unique opportunity that FG three to 46 presents.

Yeah.

Speaker Change: <unk> 32, 46 presents and novella mechanism of action and a first in class opportunity favoring an antibody against <unk> targets with a validated chemotherapy payloads.

Speaker Change: <unk> hundred 46, they offer a treatment beyond prostate cancer.

Speaker Change: With potential applications in multiple lines of metastatic castration resistant prostate cancer in combination with <unk> and other solid tumors such as colorectal cancer.

Speaker Change: FG 30 to 46 could potentially represent a paradigm shift in oncology offering not only a novel mechanism of action, but also promising efficacy safety and potential across various cancer types.

Speaker Change: We look forward to updating you on <unk> $32 46, as the studies progress I will now turn the call over to Juan to discuss the company's financial fun.

Juan Graham: Thank you, Deyaa. And again, welcome to FibroGen. I will begin my remarks with a revenue summary for the first quarter of 2024, subsequently providing financial performance details on our China business for the quarter, along with 2024 guidance for our China operations. And finally, I will wrap up with OPEX results and our cash out. For the first quarter of 2024, total revenue was $55.9 million compared to $36.2 million for the same period in 2023, an increase of 55% year over year.

Juan: And again welcome to fiber Jim.

Juan: I will begin my remarks, with our revenue summary for the first quarter of 2024 subsequently providing financial performance details on our China business for the quarter, along with 2024 guidance for our China operations, and finally, I will wrap up with Opex results in our cash outlook.

Juan: For the first quarter of 2024 total revenue was $55 9 million compared to $36 $2 million for the same period in 2023.

Juan: An increase of 55% year over year.

Juan: The total revenue increase was driven by net product revenue in China.

Juan: And one time drug product revenue recognized due to the termination of the U S rest of the World Astrazeneca agreement.

Juan: I will now provide further detail on revenue and.

Juan Graham: In the first quarter of 2024, we recorded $30.5 million of net product revenue for Roxadustat sales in China, compared to $24.2 million in the first quarter of 2023, representing an increase of 26% year over year. This increase was driven by a volume increase of 39% versus last year. Rock's two-step performance in China continues to deliver strong results, and we are delighted by this continued growth. In Q1 2024, we recorded $0.9 million in development revenue compared to $3.9 million during the first quarter of 2023.

Juan: In the first quarter of 2024, we recorded $35 million of net product revenue for <unk> sales in China compared to $24 $2 million in the first quarter of 2023.

Juan: Representing an increase of 26% year over year.

Juan: This increase was driven by a volume increase of 39% versus last year.

Juan: <unk> performance in China continues to deliver strong results and we are delighted by this continued growth.

Juan: In Q1, 2024, we recorded zero point $9 million in development revenue compared to $3 $9 million during the first quarter of 2023.

Juan Graham: Now that we have terminated the AstraZeneca-U.S.-Rest of the World Agreement, we expect our development revenue to decline in 2024 compared to last year. As we move forward, we expect quarterly development revenue to be below half a million dollars for the remainder of the year.

Juan: Now that we have terminated the Astrazeneca U S rest of World agreement, we expect our development revenue to decline in 2024 versus last year as.

Juan: As we move forward, we expect quarterly development revenue to be below half a million dollars for the remainder of the year.

Juan Graham: In Q1 2024, we recorded $24.5 million of drug product revenue compared to $2.1 million during the first quarter of 2023. As a result of the recent termination of our collaboration with AstraZeneca in the U.S. and other territories worldwide, we recorded one-time drug product revenue of $25.7 million, partially offset by a reduction of $1.2 million for Roxodustat bulk drug products sold to our partner Astellas, primarily driven by the weakening of the Japanese yen in the quarter.

Juan: In Q1, 2024, we recorded $24 $5 million of drug product revenue compared to $2 $1 million during the first quarter of 2023.

Juan: As a result of the recent termination of our collaboration with Astrazeneca in the U S rest of the World territories, we recorded onetime drug product revenue of $25 $7 million, partially offset by a reduction of $1 2 million four <unk> bulk drug products sold to our partner Astellas, primarily driven by.

Juan: The weakening of the Japanese yen in the quarter.

Juan Graham: I will now move to provide further detail on our financial performance in China. As previously mentioned by Thane, total Roxadusta Net sales from the Joint Distribution Entity, or JDE, owned by AstraZeneca and FibroGen, was $79.4 million this quarter, compared to $64.1 million in the first quarter of 2023, an increase of 24% year-over-year, highlighting the continued strong performance of the Abrenzo franchise in China, while also achieving our highest value share since launch, at 47% of the category.

Juan: I will now move to provide further detail on our financial performance in China.

Juan: As previously mentioned by pain.

Juan: <unk> reduced that net sales from the joined distribution entity or J D. E owned by Astrazeneca and fiber, Jim was $79 $4 million this quarter compared to $64 1 million in the first quarter of 2023 and.

Juan: An increase of 24% year over year, highlighting the continued strong performance of the <unk> franchise in China, while also achieving our highest value share since launch at 47% of the category.

Juan Graham: From Total Rock Seduced.net sales in China, FibroGen's net transfer price from sales to the JDE was $24.5 million for the first quarter, compared to $19.3 million in the first quarter of 2023, an increase of 27% year-over-year. Net transfer price is the best reflection of FibroGen's portion of the cash received from Roxadustat in China. During this quarter, we also released $2.6 million from de

Juan: From total <unk> net sales in China fiber Jensen that transfer price from the sales from sales to the J D. E was $24 5 million for the first quarter compared to $19 $3 million in the first quarter of 2023.

Juan: An increase of 27% year over year.

Juan: Net transfer price is the best reflection of fiber <unk> portion of the cash received from <unk> in China.

Juan: During this quarter, we also released $2 $6 million from deferred revenue.

Juan Graham: As a result, FibroGen recorded $27.1 million of net revenue for the quarter from RuxaDustat sales to the JDE and $3.4 million of direct-to-distributor sales from FibroGen China, totaling $30.5 million on a U.S. gap basis. Our revenue growth highlights the continuous robustness in execution and physician and patient adoption of Ruxidustat in China. For full year 2024, we are reiterating our forecast for FibroGen China product revenue to be between $120 to $135 million on a US GAAP basis, which assumes an underlying forecast of Ruxedusta net sales in China to range from $300 to $340 million.

Juan: As a result fiber general recorded $27 1 million of net revenue for the quarter from <unk> sales to the J D E and $3 $4 million of direct to distributor sales for fiber in China totaling $35 million under U S GAAP basis.

Juan: Our revenue growth highlights the continued robustness in execution and physician and patient adoption of <unk> starting China.

Juan: For full year 2024, we are reiterating our forecast for fiber during training product revenue to be between $120 million to $135 million in the U S. GAAP basis, which assumes an underlying forecast of <unk> net sales in China to range from $300 million to $340 million.

Juan Graham: Now moving down the income statement, operating costs and expenses for the first quarter of 2024 were $87 million compared to $112.3 million for the first quarter of 2023, a decrease of $25.3 million or 23% year-over-year. Cost of goods sold for the first quarter of 2024 was $25.8 million, which includes $21.1 million related to the AstraZeneca U.S. rest of the world revenue recognized as part of the termination agreement Excluding this one-time charge, our operating expenses came in below our total operating expense guidance, including cost of goods sold, of $70 to $80 million for the quarter.

Juan: Now moving down the income statement.

Juan: Operating costs and expenses for the first quarter of 2024 were $87 million compared to $112 $3 million for the first quarter of 2023.

Juan: A decrease of $25 $3 million or 23% year over year.

Cost of goods sold for the first quarter of 2024 was $25 $8 million, which includes $21 $1 million related to the Astrazeneca U S rest of the world revenue recognized as part of the termination agreement mentioned earlier.

Juan: Excluding somewhat such one time charge, our operating expenses came in below our total operating expense guidance, including cost of goods sold of $70 million to $80 million for the quarter.

Juan Graham: R&D expenses for the first quarter of 2024 were $38.4 million compared to $74.5 million in the first quarter of 2023, a decrease of 48% or $36.1 million, year-over-year, primarily reflecting reductions in premier level clinical trial spend, as well as other R&D infrastructure. Of our $38.4 million in R&D expenses, approximately 56% was related to PemRevLimits. 37% allocated to support our early stage pipeline, and the remaining 7% directed towards Ruxedusta development activities. SG&A expenses for the first quarter of 2024 were $22.8 million compared to $34.3 million in the first quarter of 2023, a decrease of 33.5% or $11.5 million year over year.

Juan: R&D expenses for the first quarter of 2024 were $38 $4 million compared to $74 $5 million in the first quarter of 2023.

Juan: A decrease of 48% or $36 $1 million year over year, primarily reflecting reductions in <unk> clinical trial spend as well as other R&D infrastructure.

Juan: $438 $4 million in R&D expenses, approximately 56% was related to <unk>, 37% allocated to support our early stage pipeline and the remaining 7% directed towards development activities.

Juan: SG&A expenses for the first quarter of 2024 were $22 8 million compared to $34 $3 million in the first quarter of 2023.

Juan: A decrease of 33, 5% or $11 $5 million year over year.

Juan Graham: Primarily driven by the company's cost reduction efforts, resulting in a leaner SG&A infrastructure. For the first quarter of 2024, we recorded a net loss of $32.9 million or $0.33 net loss for both basic and diluted share as compared to a net loss of $76.7 million or $0.81 per basic and diluted share for the first quarter of 2023. We reiterate our forecast of total operating expenses, including cost of goods sold, to be between $70 and $80 million for the second quarter of 2024.

Primarily driven by the car.

Juan: The company's cost reduction efforts, resulting in a leaner SG&A infrastructure.

Juan: During the first quarter of 2024, we recorded a net loss of $32 9 million or <unk> 33, net loss per both basic and diluted share as compared to a net loss of $76 $7 million or <unk> 81 per basic and diluted share for the first quarter of 2023.

Juan: We reiterate our forecast of total operating expenses, including cost of goods sold to be between $70 million to $80 million for the second quarter of 2024.

Juan Graham: Our operating expenses in the second half of 2024 will be determined by the outcomes of our two pivotal clinical trial readouts for pamreblumab in pancreatic cancer. Now shifting towards cash. As of March 31, we recorded $214.7 million in cash, cash equivalents, investments, and accounts receivable, with a reduction in operating expenses and maintaining a disciplined capital allocation approach.

Juan: Our operating expenses in the second half of 2024 will be determined by the outcome of our two pivotal clinical trial readouts for <unk> in pancreatic cancer.

Juan: Now shifting towards cash as of March 31, we recorded $214 $7 million in cash cash equivalents investments and accounts receivable.

Juan: With the reduction in operating expenses and maintaining a disciplined capital allocation approach as previously communicated we expect our cash cash equivalents investments and accounts receivable to be sufficient to fund our operating plans into 2026.

Juan Graham: As previously communicated, we expect our cash, cash equivalents, investments, and accounts receivable to be sufficient to fund our operating plans into 2026. Thank you. And now I would like to turn the call back over to. Thank you, Deyaa and Juan, for your clinical and initial updates. In closing, we are excited about our near-term prospects and the potential value they provide to stakeholders. To recap, we expect top-line data from the following two time-level map pivotal studies, our Phase 2, 3 pancreatic cancer action network precision promise trial in metastatic pancreatic cancer in mid-2024, and the LAPIS Phase 3 trial in locally advanced pancreatic cancer in the third quarter of 2024.

Juan: Thank you and now I would like to turn the call back over to Frank.

Frank: Thank you David and one for your clinical and initial updates in closing we are excited about our near term prospects and the potential value. They provide to stakeholders to recap we expect topline data from the following two pivotal studies.

Frank: Our phase III pancreatic cancer action network precision promise trial in metastatic pancreatic cancer in mid 2024.

Frank: And the LAPIS phase III trial in locally advanced pancreatic cancer in the third quarter of 2024.

Juan Graham: Rox Ducet continues to perform very well in China, where we expect an approval decision for our SNDA for chemotherapy-induced anemia in the second half of this year, and our partner Estelle continues with the commercialization of Rox Ducet in Europe, Japan, and other markets. Additionally, we are excited to regain rights for ROX2STAT for U.S. ROW territories from AC and have been exploring potential partnering opportunities in anemia inpatients with lower With our early-stage pipeline, we recently recorded compelling top-line data from a Phase I monotherapy study of FG3246 in metastatic castration-resistant prostate cancer and will publish the totality of the Phase I data in an upcoming manuscript.

Frank: <unk> continues to perform very well in China, where we expect an approval decision of our S. NDA for chemotherapy induced anemia indication.

In the second half of this year and our partner ourselves continues to the commercialization of <unk> in Europe, Japan and other markets.

Frank: Additionally, we are excited to regain rights for <unk> for use <unk> territories from AC and have been exploring potential partnering opportunities and anemia in patients with lower risk Mds.

Frank: With our early stage pipeline, we recently reported compelling topline data from the phase one monotherapy study of FG $32 46 in metastatic castration resistant prostate cancer and we'll publish the totality of the phase one data in an upcoming manuscript.

Thane Wettig: We will be presenting top-line data from the Dose Escalation Phase 1B study of FG3246 in combination with intralutamide in MCRPC at the 2024 American Society of Clinical Oncology Annual Meeting in June. We anticipate initiating our Phase 2 monotherapy dose optimization study of FG3246 in MCRPC in the second half of 2024. We anticipate FDA clearance of our IND for FG3165, our anti-Gal-9 antibody, in the near term, and we anticipate filing an IND for FG3175, our anti-CCR8 antibody, in 2025. Additionally, we have a strong balance sheet and expect our current cash position, as Juan said, to fund operations into 2026.

Frank: We will be presenting top line data from the dose escalation phase <unk> study of FG $32 46 in combination with <unk>.

Frank: MCR PC at the 2020 for American Society of clinical oncology annual meeting in June.

Frank: We anticipate initiation of our phase II monotherapy dose optimization study of FG 30 to 46.

Frank: AMC RPC in the second half of 2024.

Frank: We anticipate FDA clearance of our IND for <unk> 165, our anti <unk> antibody in the near term.

Frank: And we anticipate filing an IND for FG $3 75, our anti <unk> antibody in 2025.

Frank: Additionally, we have a strong balance sheet and expect our current cash position is one said to fund operations into 2026.

Thane Wettig: In summary, we will continue to execute against our strategic priorities as we strive to attain a valuation that we believe is more reflective of our current and future ROC's reduced debt revenue stream, near-term PAM Revlimat readouts and pancreatic cancer, our oncology pipeline, and our strong balance. I would like to thank all the employees of FibroGen for their continued hard work and resilience over the last few months. I would now like to turn the call over to the operator of Q&A.

Frank: In summary, we will continue to execute against our strategic priorities as we strive to attain a value equation that we believe is more reflective of our current and future <unk> that revenue stream near term Pam rivaling that of Readouts in pancreatic cancer.

Frank: Oncology pipeline and our strong balance sheet I.

Speaker Change: I would like to thank all the employees of <unk> for their continued hard work and resilience over the last few months I would now like to turn the call over to the operator for Q&A.

Thane Wettig: Thank you. As a reminder, to ask a question, please press star 1 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 1 again. One moment for questions. Our first question comes from Andy Hesai with William Blair.

Speaker Change: Thank you as a reminder to ask a question. Please press star one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one again, one moment for questions.

Operator: You may proceed. Great, thanks for taking our questions and congratulations on the progress. So, two quick ones and I have a follow-up. I'm pretty intrigued by your comment about slowing of the event rates as you wrap up the LAP study. Could you educate us on why that is?

Operator: Our first question comes from Andrew <unk> with <unk>.

Operator: William Blair you May proceed.

Sure.

Andrew: Great. Thanks for taking our questions and congratulations on the progress so.

Andrew: Two quick ones and then I have a follow up.

Speaker Change: And pretty intrigued by your comment about.

William Blair: Slowing of the event rates as you wrap up the lap steady could you educate us on why that is.

Andy Hesai: You know, in terms of, you know, factors kind of leading to the third quarter readout. And jumping back to Roxadustat, there's a nice uptick, as you mentioned, to 47%, I guess, market value share. Can you also explain why that is?

William Blair: In terms of.

William Blair: Factors, leading to the third quarter readout.

William Blair: And jumping back to <unk>, there is a nice uptick as you mentioned a 47%.

Speaker Change: I guess.

Speaker Change: Market.

Andy Hesai: What's driving the uptick in uptake? Yeah, hey, Andy, thanks for your questions. On the lapis and the slowing event rate, you know, it's really just math.

Speaker Change: Sure.

Speaker Change: Can you also explain why that is what's driving the uptick in <unk>.

Speaker Change: Uptake.

Thane Wettig: You know, we enrolled 284 patients. There is a certain number of OS events that need to be accrued to hit the pre-specified power that we had articulated in our SAP. And so as you accrue OS events, there are fewer patients to then accrue the remaining OS events. And that's where we are with that last part of the trial, where there are thankfully a number of patients who are still alive, but fewer patients to accrue these additional OS events.

Speaker Change: Yes, Hey, Andy Thanks for your questions on the the LAPIS and the slowing of event rate, yes, it's really just math.

Speaker Change: We enrolled 284 patients.

Speaker Change: There are certain number of OS events that need to be accrued to hit the pre specified power that we had articulated in our SAP.

Speaker Change: And so as you accrue OS events therapeutic fewer number of patients to then accrue the remaining OS events and Thats, where we are with that last part of the trial, where there are thankfully a number of patients who are still alive, but fewer patients.

Speaker Change: To accrue these additional OS events, and it's just a common occurrence and an event driven oncology trial or any event driven trial.

Speaker Change: Of this of this type and so like.

Speaker Change: Like we said in our prepared remarks, we're looking every week at the number of OS events.

Thane Wettig: And we'll continue to keep you updated once we reach that number of OS events that reach the pre-specified power that will allow us to then lock the database, perform the analysis, and then release top-line results. And as we said in the remarks, we expect that to be sometime in Q3. I would anticipate it to be earlier in Q3, but we wanted to say Q3 as opposed to Q2, which was the update last time, just to reflect the most recent trend of event rates. Does that make sense?

Speaker Change: We're getting very close to that pre specified number and we'll continue to keep you updated.

Speaker Change: Once we receive on once we reach that.

Speaker Change: That number of OS events that that reached the Prespecified power that will allow us to then.

Speaker Change: Lock the database perform the analysis and then released topline results and as we said in the remarks that we expect that to be sometime in Q3, I would anticipate it to be earlier in Q3, but we wanted to say Q3 as opposed to Q2, which was the update last time just to reflect the most recent.

Trend of event rates.

That makes sense.

Thane Wettig: Yeah, that's very helpful. Thank you. Okay. And then, with respect to the 47% value share for Roxa-Dewstead, in addition, obviously, to the continued excellent execution by the AZ and China FibroGen teams, I'll turn it over to Chris for some additional comments. Hi, Andy. The local team is not really seeing any fundamental changes in market forces for this optimistic outlook. There are two factors that we can think of.

Speaker Change: Yes, that's very helpful. Thank you, Okay, and then with respect to the 47% value share for <unk>. In addition, obviously to the continued excellent execution by the AZ and fine up China fibers team I'll turn it over to Chris for some additional comments.

Chris: Hi, Andy.

Chris: The local team is not really seeing any fundamental changes in market forces, but this optimistic outlook.

Christine L. Chung: One is obviously the NRDL price cut that we experienced, about seven percent. So if you believe in price sensitivity, that might have helped a little bit. The second factor is the introduction of a new HIF entrance, which we think became a little bit of a second push for the class. And because of that, we have an installed base. We have a very, very strong sales force. We think it has actually helped us a little bit.

Chris: Two factors that we can cause one opportunity.

Chris: The deal price cuts that we experienced.

Chris: So if you believe in price sensitivity.

Chris: Is that might've touched a little bit the second factor is.

Chris: Production of EMEA.

Chris: Sure.

Chris: <unk>, which we think.

Chris: Became a little bit of a second question for the class.

Chris: Because of that we have a installed base we have a very strong sales force, we think it actually helped us a little bit but overall, we remain optimistic about the market outlook, but we do not believe this reflects any fundamental change in the market outlook and voices.

Christine L. Chung: But overall, we remain optimistic about the market outlook, but we do not believe this reflects any fundamental change in the market outlook and forces. And I think, Andy, once you establish a momentum like Roxaducet has done in China and you create this installed base of prescribers, this installed base of patients, and it gets on this momentum role like it's been on really since it launched. And the reason it's performing like that is because of the positive experience that it provides for patients and clinicians.

Chris: I think Andy we know once you establish a momentum like the <unk> that is done in China and you create this installed base of prescribers. This installed base of patients and it gets on this momentum role I can spin on really since it launched.

Andy: And the reason, it's performing like that is because of the positive experience that is.

Andy: It provides for for patients and clinicians and so its just almost as a <unk>.

Christine L. Chung: And so it's just almost a self-perpetuating set of momentum that we expect to, you know, continue to see just because the drug performs extremely well at the patient level. Got it, got it.

Self perpetuating.

Andy: Set of momentum that we expect to continue to see just because the drug performs extremely well at the patient level.

Thane Wettig: That's helpful. Thank you. Jumping to 3246, I guess, looking across the, And this is the paradigm for prostate cancer. Most of the options out there are monotherapies, I guess, with the exception of PARPs. As you kind of think about the double of it, the endolutamine plus 3246 combination, in your discussions with the KLLs, what are they looking for? Just to kind of set up our expectations heading into the ASCO readout, is there a bar for success in terms of PSA-50 reduction, PFS, or response rate based on resist? Yeah, it's a great question, Andy.

Speaker Change: Got it got it.

Speaker Change: That's helpful. Thank you.

Speaker Change: Jumping to $32 46.

Speaker Change: Looking across the ditch.

Speaker Change: The paradigm for prostate cancer most of the options out there as a monotherapy with the exception of parks as you kind of think about the double of the <unk>.

Speaker Change: Dilutive mine plus 30 to 46 combination.

Speaker Change: In your discussions with the Kols.

Speaker Change: What are they looking for just kind of set up our expectations heading into the ask a readout is there like a bar for success in terms of P&L.

Speaker Change: PSA 50 reduction.

Speaker Change: PFS or response rate based on the shift.

Deyaa Adib: I'm going to turn it over to Deyaa for his thoughts. So, let me answer. Thank you for the question. First of all, it's a dose escalation study in combination with enzalutamide, and it will include the patient populations from the first first and second blind setting prior to receiving docetaxel in the MCRPC paradigm. So having said that, we are looking here to prove the hypothesis that patients who have been previously exposed to a second generation ARSI are truly overexpressing CG46. So this is what the objective of the trial is.

Speaker Change: Yes, it's a great question and im going to turn it over to Dave for his thoughts.

Dave: So let me answer. Thank you for the question first of all its a dose escalation study in combination with Zillow termites.

Dave: And it will include the patient populations from the first first and second line setting.

Dave: To receiving docetaxel in the MCR EPC.

Dave: Paradigm, so having said that.

Dave: We are looking here to prove the hypothesis that patients who have been previously exposed to a second generation or a size.

Dave: Truly over expressing CD 46. So this is what the objective of the trial.

Deyaa Adib: Secondly, there has not yet been a threshold or a benchmark associated with the results because it's still a phase one escalation and will be followed by cohort expansion. So, based on what we see in terms of patient population first versus second line setting clinical benefits, we will be able to decide and discuss with KOLs what would be a clinically meaningful benefit. Not just that, but also what will be the threshold for radiographic progression-free survival, because this will be really the endpoint upon which we can start thinking about a registration path when we combine it with enzalutamide? Regarding PSA-50 or objective response rate, as you are aware, PSA-50 is a pharmacodynamic biomarker.

Dave: Secondly, there has not been yet a threshold or a benchmark associated with the results because it is still a phase one.

Dave: Galatian and will be followed by cohort expansion. So based on what we see in terms of patient population first versus second line setting.

Dave: Clinical benefits, we will be able to decide and discuss with kols what would be a clinically meaningful benefit not just at also what will be the threshold for AI geographic progression free survival. Because this will be really the endpoint upon which we can seem to start thinking about.

Registration path when we combined with <unk>.

Deyaa Adib: It's an indication of clinical activity, but it's not a clear indication of how long patients will have disease-free survival or progression-free survival. In terms of objective response rate, I also would like to remind you that it will pertain only to patients who have measurable disease at baseline, so we may see signals there, but remember that about 40% of patients with prostate cancer will show up with measurable disease, and 60% will show up with only bone lesions in the metastatic setting. I got it. That's a helpful context statement.

Dave: Regarding PSA 50, or objective response rate as you are aware PSA 50 is a pharmacodynamic biomarker.

Dave: One indication of clinical activity, but it's not a clear indication for how long patients will have disease free survival or progression free survival.

Dave: In terms of objective response rates I also would like to remind you. It will pertain only to patients who have measurable disease at baseline. So we may see signals, there, but remember that about 40% of patients with prostate cancer will show up with measurable disease, and 60% will show up with only.

Dave: Bone lesions in the metastatic setting.

Speaker Change: Got it that's helpful context. Thank you.

Speaker Change: Thank you.

Andy Hesai: Thank you. Thank you. One moment for questions. Our next question comes from Jason Gerberry with Bank of America. You may proceed. Hi, good afternoon. This is Dina on behalf of Jason.

Speaker Change: One moment for questions.

Speaker Change: Our next question comes from Jason <unk> with Bank of America, You May proceed.

Speaker Change: Hi, Good afternoon. This is dana on for Jason Congrats.

Jason Matthew Gerberry: Congratulations on the progress this quarter and thank you for taking our question. Just one from us on FG3246: could you just explain the reason for the phase two dose optimization study that you're planning on initiating in the second half of this year? Like is there more dose optimization necessary to supplement the phase one data?

Dana: Congrats on the progress this quarter and thank you for taking our question.

Dana: Just one from us on.

F 32, 46 could you explain the reason for that.

The phase two dose optimization study that youre planning on initiating in the second half of this year.

Dana: Is there more dose optimization necessary to supplement the phase one data.

Dina: Because it sounds like you're meeting with FDA ahead of, you know, kind of launching this phase two trial. So, just curious how it will inform your phase two, three, you know, registrational trial. Thank you. Yeah, it's a really good question, Dina.

Speaker Change: It sounds like Youre meeting with FDA, you had a ahead of kind of watching to see two trials. So just curious how it will inform you.

Speaker Change: Your phase three Registrational trial. Thank you.

Thane Wettig: Thanks for that. Before I hand it over today, I'll stress that we have spent a lot of time thinking about what is the optimal design that not only will produce the clinical data that we believe we'll need to see but also will be done, and will do so in an efficient way, given how competitive the space is. And I think it's, you know, it's a testament to Deyaa and the experience that he brings, not only in terms of overall clinical development experience but also in the prostate cancer space. So, let me turn it over to him and have him kind of walk you through our thinking.

Speaker Change: Yes, it's a really good question Dana thanks for that before I hand, it over to Dave I'll stress that we have spent a lot of time thinking about what is the optimal design.

Dave: Not only will produce the clinical data that we believe will need to see but also will be done we'll do so in an efficient way given how competitive the spaces.

Speaker Change: I think it is.

Dave: As a testament to data and the experience that he brings not only in terms of overall clinical development experience, but also in the prostate cancer space. So let me turn it over to him and have them kind of walk you through our thinking and again.

Deyaa Adib: And again, this is pending alignment with the FDA once we do meet with them, but he'll provide a little bit more guidance in terms of, you know, why we're thinking the way we're thinking. Thank you, Thane. So to answer your question, the purpose of having this phase two component of the phase two, three design is to further optimize the dose that will be later on called the recommended phase three dose. And this is, essentially, if you go backwards to 2023, the FDA has initiated Project Optimist.

Speaker Change: This is pending alignment with the FDA once we do meet with them, but it will provide a little bit more guidance in terms of why were thinking the way we are thinking.

Speaker Change: Thank you think so to answer your question the purpose of having this phase II component of the phase III design is to further optimize the dose that will be later on calls the recommended phase II dose and this is essentially if you go backwards in 2023, the MTA has in.

Speaker Change: <unk> project, Optimus and growth across the board in drug development to ensure that sponsors have identified the right dose moving forwards that will offer patients maximum clinical benefit with the lowest risk in terms of adverse events. So we are essentially.

Deyaa Adib: And it goes across the board in drug development to ensure that sponsors have identified the right dose moving forward that will offer patients maximum clinical benefit with the lowest risk in terms of adverse events. So we are essentially complying with FDA requirements to optimize the dose before we start the phase three registration trial. So this is our thinking about dose optimization. And one final comment, Dean, in addition to what Deyaa articulated, we also plan on, again, pending concordance with the FDA, treating all the patients in this dose optimization phase with the PET-46 biomarker as well and then doing a post hoc analysis to assess the correlation of CD46 expression and response to the ADC. And so that's also an important component of the dose optimization part of the ongoing design. Got it.

Deyaa Adib: Thank you so much. Thank you. One moment for questions. Our next question comes from Paul Choi with Goldman Sachs. He may proceed. Hi, thank you.

Complying with the FDA requirements to optimize the dose and before we start the phase III registration trial. So this is our thinking about those.

Speaker Change: Those optimization.

Speaker Change: And then one final comment Deane in addition to what data articulated as we also plan on again pending <unk>.

Speaker Change: <unk> with the FDA plan on treating all of the patients in this dose optimization phase.

Speaker Change: With the pet 46, biomarker as well and then doing a post hoc analysis to assess the correlation of CD 46 expression and response to the ADC and so that's also an important component of the dose optimization part of the ongoing design.

Speaker Change: Got it thank you so much.

Speaker Change: Yeah.

Speaker Change: Thank you.

Speaker Change: One moment for questions.

Speaker Change: Our next question comes from Paul Choi with Goldman Sachs. You May proceed.

Paul Choi: Good afternoon, and thank you for taking our questions. Just to follow up on the prior question with regard to the Phase II monotherapy dose optimization, your timeline calls for data potentially in 2026. I'm just curious if there's anything in terms of your insight from the monotherapy portion, particularly the higher doses, that might be able to accelerate that timeline for the Phase II dose optimization. My second question is just with regard to Evrenzo in China.

Paul Choi: Hi, Thank you good afternoon, and thank you for taking our questions.

Paul Choi: Just to follow up on the prior question with regards to the phase II monotherapy dose optimization.

Paul Choi: Your timeline calls for.

Paul Choi: Potentially in 2020 I'm just curious if you if theres anything in terms of your insight from the monetary portion in particular at the higher doses that might be able to accelerate that timeline for the phase two dose optimization.

Paul Choi: My second question is just with regard to.

Paul Choi: You've maintained your updated timing for the CIA indication for the second half of this year, but just to confirm, your expectation for inclusion into NRDL would be no earlier than calendar 2026. If you could confirm that, that would be great. Thank you. Thanks, Paul. Regarding the kind of the 2026 timeline for FG3246, you know, now that we've taken a step back and that we've done a lot more thinking around this proposed phase two slash three design that we will discuss with the FDA, it's probably a bit premature to talk about when we would see the totality of that dose optimization data set. Our goal would be to get this trial started as quickly as we can after discussion with the And then, you know, begin execution.

Our friends and <unk>.

Paul Choi: China.

Paul Choi: You've maintained your updated timing for the <unk>.

Paul Choi: Indication for second half of this year, but just to confirm your expectation for inclusion in <unk> would be for no earlier than calendar 2026, if you could kind of confirm that that'd be great. Thank you.

Speaker Change: Yeah. Thanks, Paul regarding the that kind of a 2026 timeline for FG $32 46, now that we've taken a step back and that we've done a lot more thinking around this proposed phase II <unk> III design that we will discuss with the FDA, it's probably a bit premature to talk about when we would.

Speaker Change: See the totality of that dose optimization dataset, our goal would be to get this trial started as quickly as we can after discussion with the FDA in alignment with them and then begin execution. We think it will be a has the potential to be a rapidly enrolling trial, it's not at all.

Thane Wettig: We think it will be a has the potential to be a rapidly enrolling trial. It's not a, you know, huge cohort of patients in this dose optimization phase. And so our plan would be to get the execution as quickly as we possibly can. Deyaa, would you add anything to that? No, to your point, Dane, this will be a data-driven study, and it will inform us in terms of not only dose optimization or the recommended phase three dose, but also enable us to select the patients who will get the best clinical benefit out of this ADC going into the phase three component of the trial. Yeah, and then.

Speaker Change: Huge cohort of patients in this dose optimization phase and so our plan would be to get to execution as quickly as we possibly can Dave would you add anything to that no.

Dave: To your point thing this will be a data driven study and it will inform us in terms of not only those optimization or the recommended phase II dose, but also enabling us to select the patients who will make the best clinical benefit out of this ADC going into the phase III component of the trial.

Dave: And then.

Deyaa Adib: Paul, I'll ask Chris to comment on the updated CIA timing guide. So, Paul, we updated the timing of the projected approval timeframe based on the current progress at the CD in the review of the technical filing. We are projecting a second half of 2024, although right now we're not in a position to comment on the regulatory review process, but to be conservative, we moved it to the second half. To answer your specific question, would that mean that we would not have reimbursement for the indication of CIA until January 1st, 2026? The answer is yes.

Dave: Paul I'll ask Chris to comment on the updated CIA timing guidance.

Chris: So Paul we updated the timing of the projected approval timeframe based on the current progress at the <unk> review of the technical finally, we are projecting a second half 2024, although right now we're not in a position to comment on the regulatory review process.

Yes, but to be conservative we moved it to second half to answer your specific question would that mean that we would not have reimbursement for the indication of CIA until January one 2026. The answer is yes in order for us to qualify for an RTL starting Jamie for 2025, we would need to be approved by.

Chris: 2024 June 30th.

Speaker Change: Okay, great. Thank you.

Speaker Change: And so Paul we do believe that there's still a chance to hit the.

Speaker Change: The approval timing that would allow us to have in our deal inclusion for the CIA indication in 2025, right and so the team continues to work very closely with the <unk> on the review, it's just premature at this point in time to be able to handicap, whether or not we'll be we'll be able to achieve that but.

Speaker Change: Please note that it is a really important goal for us.

Speaker Change: Okay, great. Thanks for clarifying that thank you.

Speaker Change: Thank you I would now like to turn the call back over to <unk> for any closing remarks.

Speaker Change: Hey, guys. We appreciate your participation in today's Investor call and your continued interest in <unk> and thank you for the questions enjoy the rest of your day.

Speaker Change: Thank you. This concludes the conference. Thank you for your participation you may now disconnect.

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Christine L. Chung: In order for us to qualify for NLDL starting January 1st, 2025, we would need to be approved by 2024, June 30. Okay, great. Thank you. Yeah, and so Paul, you know, we do believe that there's still a chance to, you know, hit the approval timing that would allow us to have inter-DL inclusion for the CIA indication in 2025, right? And so the team continues to work, you know, very closely with the CDE on the review. It's just premature at this point in time to be able to handicap whether or not we'll be able to achieve that. But, you know, please know that it's a really important goal for us. Okay, great.

Speaker Change: Good day and thank you for standing by welcome to the five regions first quarter 2024 earnings Conference call. At this time all participants are in a listen only mode. After the speaker's presentation there'll be a question and answer session to ask a question. During this session. Please press star one one on your telephone and wait for your name to be an hour.

Speaker Change: To withdraw your question. Please press star one again, please be advised that today's conference is being recorded I would now like to hand, the conference over to your speaker today, David <unk>.

Paul Choi: Thanks for clarifying that. Thank you. Thank you. I would now like to turn the call back over to Thane Wettig for any closing remarks. Yeah, guys, we appreciate your participation in today's investor call and your continued interest in FibroGen. And thank you for the questions. Enjoy the rest of your day.

Vice President Investor Relations.

Thane Wettig: Thank you. This concludes the conference. Thank you for your participation. You may now disconnect. © The Ultimate Parody Site! ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? Good day and thank you for standing by.

Speaker Change: Okay.

Good afternoon, everyone. Thank you for joining today to discuss our first quarter 2024 financial and business results I'm, David de La <unk>, Vice President of corporate SG&A and Investor Relations at fiber Jim <unk>.

Joining me on today's call are saying why they are chief Executive Officer, Dr. Dan <unk>, Our Chief Medical Officer, One Graham our Chief Financial Officer, Dr. John Hunter, Our Chief Scientific Officer, and Chris Chung, Our senior Vice President of China operations.

Speaker Change: In that statement.

Speaker Change: More complete description of these and other material risks can be found in <unk> filings with the SEC, including our most recent Form 10-K and Form 10-Q fiber.

Operator: Welcome to FibroGen's first quarter 2024 earnings conference 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, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, David DeLucia, Vice President, Investor Relations. Good afternoon, everyone.

Speaker Change: With that I'd like to turn the call over to our CEO <unk> <unk>.

CEO: Thank you Dave Good afternoon, everyone and welcome to our first quarter 2024 earnings call on today's call I will focus our stakeholders on the four strategic pillars shaping our company's future trajectory. Additionally, I'll offer insights into the progress of our <unk> and <unk> programs Dr.

CFO: We will review the financials after which we will open the call for your questions.

CFO: Starting on slide three <unk> has four key strategic pillars that we believe offer significant value today.

First is <unk>, where we are preparing for readouts from two pivotal phase III studies in pancreatic cancer in the coming months, we plan on releasing top line data from precision promise pancreatic cancer action network's phase two three adaptive platform trial for metastatic pancreatic cancer and from our ongoing.

CFO: LAPIS phase III trial in locally advanced pancreatic cancer.

Thane Wettig: Good afternoon, everyone, and welcome to our first quarter 2024 earnings call. On today's call, I will focus our stakeholders on the four strategic pillars shaping our company's future trajectory. Additionally, I'll offer insights into the progress of our PembevelMab and Roxadustat programs. Dr. Deyaa Adib, our chief medical officer, will review the top line data from our CD46 targeted antibody drug conjugate FG3246. In metastatic castration-resistant prostate cancer and articulate why we feel so strongly about our recently released phase one top line results. And Juan Graham, our CFO, will review the financials, after which we will open the call for your questions.

CFO: Pancreatic cancer is a disease with substantial unmet clinical need and represents a significant commercial opportunity for <unk>, which has demonstrated an effect in both preclinical and early clinical studies in pancreatic cancer, and which we will detail in a moment.

CFO: Second is <unk> <unk> is approved in over 40 countries generates significant net revenue and positive cash flow and provides <unk> with material and growing economics through our partnerships with Astrazeneca and Astellas pharma.

CFO: We're expecting an approval decision from the China authorities in the second half of 2024 for chemotherapy induced anemia, which if approved would represent meaningful revenue growth on top of the substantial revenue generated by <unk> in anemia associated with chronic kidney disease.

CFO: Biogen has regained the rights to <unk> from Astrazeneca in the U S and <unk> territories, excluding China and South Korea.

CFO: This allows us the opportunity to potentially partner Rox, Zeus that in certain indications with high unmet needs such as anemia in patients with lower risk Myelodysplastic syndromes.

CFO: Third is our early stage oncology pipeline, we are very excited about the potential of these programs.

CFO: <unk> $32 46 is a first in class potent antibody drug conjugate or ADC targeting CD 46 for the treatment of metastatic castration resistant prostate cancer and potentially other solid tumors.

CFO: This program also includes the development of an associated CD 46 targeted pet biomarker.

CFO: In April we released compelling data from our <unk> $32 46 phase one monotherapy trial, which Dale will go into later on the call.

CFO: In addition to FG $32 46, we have recently submitted an IND for FG $31 65, our anti collected nine monoclonal antibody and await FDA clearance of the application.

We are also planning to final on IND for F. G 31, 75, our anti ACC or eight monoclonal antibody in 2025.

The fourth pillar is our strong cash position, we finished the quarter with approximately $214 7 million in cash cash equivalents investments and accounts receivable, we expect our strong balance sheet to be sufficient to fund our operating plans into 2026.

CFO: In summary, we believe there are a few biotechnology companies of our market cap that have such a compelling mix of commercial late stage and early stage assets. When you combine our assets our strong balance sheet and the quality of our talented colleagues of fibers and we believe that we have a strong foundation to drive significant shareholder value creation today.

Thane Wettig: Starting on slide three, FibroGen has four key strategic pillars that we believe offer significant value today. The first is PemRevimab, where we are preparing for readouts from two pivotal phase three studies in pancreatic cancer. In the coming months, we plan on releasing top-line data from Precision Promise, the Pancreatic Cancer Action Network's Phase 2-3 Adaptive Platform trial for metastatic pancreatic cancer, and from our ongoing LAPIS Phase 3 trial in locally advanced pancreatic cancer. Pancreatic cancer is a disease with substantial unmet clinical need and represents a significant commercial opportunity for Pamrevimab, which has demonstrated an effect in both preclinical and Second, is Roxadustat.

CFO: And into the future.

Thane Wettig: Roxadustat is approved in over 40 countries, generates significant net revenue and positive cash flow, and provides FibroGen with material and growing economics through our partnerships with AstraZeneca and Astellas Pharma. We're expecting an approval decision from the Chinese authorities in the second half of 2024 for chemotherapy-induced anemia, which, if approved, would represent meaningful revenue growth on top of the substantial revenue generated by roxidustat for an FibroGen has regained the rights to RoxyDucet from AstraZeneca in the U.S. and ROW territories, excluding China and South Korea.

Thane Wettig: This allows us the opportunity to potentially partner Roxazustat in certain indications with high-end met needs, such as anemia in patients with lower risk myodysplastic syndrome. Third, we are very excited about the potential of these programs.

CFO: Moving to slide five <unk> is a novel anti CTG human monoclonal antibody in clinical development for the treatment of metastatic pancreatic cancer and locally advanced unresectable pancreatic cancer or L. A PC Tam.

CFO: <unk> has demonstrated dose and exposure related responses in an early stage pancreatic cancer trial and having been studied in over 1000 patients across various conditions.

CFO: Favorable safety and Tolerability profile.

Thane Wettig: Moving to slide 5, PamrevoMab is a novel anti-CTGF human monoclonal antibody in clinical development for the treatment of metastatic pancreatic cancer and locally advanced unresectable pancreatic cancer, or LAPC. Pam Revlimab has demonstrated dose and exposure-related responses in an early stage pancreatic cancer trial and, having been studied in over 1,000 patients across various conditions, a favorable safety and tolerability profile. I would now like to discuss the PamrevoMap opportunity in pancreatic cancer in more detail, starting on slide 6.

CFO: I would now like to discuss the <unk> opportunity in pancreatic cancer in more detail starting on slide six.

CFO: Pancreatic cancer represents one of the largest unmet needs in oncology with an annual incidence of nearly half a million patients across the major regions combined.

CFO: This includes approximately 60000 pediatric patients in the U S.

CFO: There is an overall five year disease free survival rate of only 12, 5% and for metastatic cancer survival rate is approximately 3%. Unfortunately, there have not been any major therapeutic advances for quite some time.

Thane Wettig: And for metastatic cancer, the survival rate is approximately 3%. Unfortunately, there have not been any major therapeutic advances for quite some time. On slide 7, we provide an overview as to why we believe PAMREVIMAB can provide benefits to patients diagnosed with pancreatic cancer. Based on preclinical data, connective tissue growth factor, or CTGF, plays an important role in the growth and progression of pancreatic tumors.

CFO: On slide seven we provide an overview as to why we believe <unk> can provide benefits to patients diagnosed with pancreatic cancer.

CFO: Based on preclinical data connective tissue growth factor or CTG App plays an important role in the growth and progression of pancreatic tumors.

Thane Wettig: Mouse pancreatic tumor studies have shown that Pamrevimab, by inhibiting the biological activity of CTGF, can have both direct anti-tumor effects and effects on the surrounding stroma, providing a strong clinical rationale for use in both locally advanced and metastatic pancreatic cancer. Moving to slide eight. We would like to reference the data from our Open Label Dose Escalation Phase 1-2 trial in patients with locally advanced stage 3 or metastatic stage 4 pancreatic cancer.

CFO: Mouse pancreatic tumor studies have shown that Pam rebel map by inhibiting the biological activity of CTG.

CFO: Can have both direct anti tumor effects.

CFO: And effects on the surrounding stroma, providing a strong clinical rationale for use in both locally advanced and metastatic pancreatic cancer.

CFO: Moving to slide eight we.

CFO: We would like to reference the data from our open label dose escalation phase <unk> trial in patients with locally advanced stage III or metastatic stage four pancreatic cancer almost 90% of these 75 patients were in fact metastatic with only nine having locally advanced disease.

Thane Wettig: Almost 90% of these 75 patients were in fact metastatic, with only 9 having locally advanced disease. Pamrevlimab was evaluated in combination with gemcitabine and erlotinib as first-line therapy. An important observation in the study was that enhanced clinical benefit was observed at higher drug exposure levels. Once drug plasma levels reached a TROP threshold of 150 micrograms per ml, a number of important results were found.

CFO: <unk> was evaluated in combination with Gemcitabine and <unk> as first line therapy.

An important observation in this study was it enhanced clinical benefit was observed at higher drug exposure levels.

CFO: Once drug plasma levels reached a trough threshold of 150 micrograms per ml a number of important results were found the most notable.

Thane Wettig: The most notable result in this study was that one-year survival was 37% for patients who had circulating PAM-Revlimab levels of 150 micrograms per mL or higher versus 11% for those with lower plasma levels. These results from the higher exposure cohort patients also included improved median overall survival and improved median progression-free survival. Moving to slide 9, in late January, we announced the completion of the PAMREVOMAB arm and Precision Promise Pancreatic Cancer Action Network Space 2-3 Adaptive Platform Trial for Metastatic Pancreatic Cancer, which evaluates PamrevoMab in combination with the chemotherapy treatments gemcitabine and nabpaclitaxel for patients with metastatic pancreatic ductal adenocarcinoma.

CFO: <unk> result in this study was that one year survival was 37% for patients who had circulating <unk> levels of 150 micrograms per ml or higher versus 11% for those with lower plasma levels.

CFO: These results and the higher exposure cohort patients also included improved median overall survival and improved median progression free survival.

CFO: Moving to slide nine in late January we announced the completion of the <unk> precision promise pancreatic cancer action that workspace to three adaptive platform trial for metastatic pancreatic cancer, which evaluates <unk> in combination with the chemotherapy treatments Gemcitabine and Nab Paclitaxel.

CFO: For patients with metastatic pancreatic ductal adenocarcinoma.

Thane Wettig: The Precision Promise Trial is a Phase 2-3 registrational trial that is being executed at the top pancreatic cancer centers in the United States. The primary endpoint of the trial is overall survival. In this study, Pamrevelumab is being evaluated in both first and second line metastatic disease. Slide 10 provides additional details on the Precision Promise Study, which is comprised of two stages. In the initial stage of the study, or stage 1, 100 patients with metastatic pancreatic cancer received Pamiravomab in combination with gemcitabine and nabpaclitaxin.

CFO: The precision promise trial as a phase two three Registrational study that is being executed at the top pancreatic cancer centers in the United States.

CFO: The primary endpoint of the trial is overall survival in this study <unk> is being evaluated in both first and second line metastatic disease.

CFO: Slide 10 provides additional details on the precision promise study, which is comprised of two stages in.

CFO: In the initial stage of the study or stage, one 100 patients with metastatic pancreatic cancer receive <unk> in combination with gem side of being in Nab Paclitaxel.

Thane Wettig: Guided by Bayesian principles, the graduation threshold for PAMREVIMAB was a protocol pre-specified greater than or equal to 35% predictive probability of success for the primary endpoint of overall survival at the completion of the trial. The PAMREVIMAB arm successfully graduated to Stage 2 in the third quarter of 2022, and an additional 75 patients were enrolled, receiving the same PAMREVIMAB treatment regimen as in Stage 1. All patients were dosed until disease progression, and the final analysis is based on the data collected for all patients up to 12 months after the last patient initiated treatment, including patients enrolled during the analysis period between stages one and two. A total of 213 patients participated in the PAMREVIMAB arm of the study. The Pemrevemeb arm of the Precision Promise Trial was completed in late January of this year.

CFO: Guided by Bayesian principles congratulation threshold for Pam rebel Mab was a protocol pre specified greater than or equal to 35% predictive probability of success for the primary endpoint of overall survival at the completion of the trial.

CFO: The <unk> arm successfully graduated to stage two in the third quarter of 2022, and an additional 75 patients were enrolled.

CFO: <unk> the same time rebel mab treatment regimen as in stage one.

CFO: All patients were dosed until disease progression and the final analysis is based upon the data collected for all patients up to 12 months after the last patient initiated treatment.

CFO: Including patients enrolled during the analysis period between stages, one and two.

CFO: A total of 213 patients participated in the <unk> arm of the study the.

CFO: The <unk> arm of the precision promise trial was completed in late January of this year.

Thane Wettig: PAMREVIMAB is the first experimental arm in the Precision Promise Trial to meet its pre-specified threshold for graduation to Stage 2, and we now expect to report top-line data in mid-2024, reflecting PAMCAN's updated timing to complete database lock and subsequent analysis of the top-line results by the Independent Statistical Monitoring Committee. On slide 11, we provide an overview of the Global Phase 3 LAPIS trial. A double-blind, placebo-controlled trial in 284 patients with locally advanced, unresectable pancreatic cancer comparing Pamrevelmab to placebo in combination with standard-of-care chemotherapy

CFO: <unk> is the first experiment alarm in the precision promise trial to me Thats, a prespecified threshold for graduations in stage two and we now expect to report topline data in mid 2024, reflecting pan cancer updated timing to complete database lock and subsequent analysis of the topline results by the independent Statistical monitoring Committee.

CFO: On slide 11, we provide an overview of the global phase III LAPIS trial.

CFO: Double blind placebo controlled trial in 284 patients with locally advanced Unresectable pancreatic cancer, comparing <unk> to placebo in combination with standard of care chemotherapy.

Thane Wettig: The primary endpoint is overall survival. Given LAPIS is an event-driven trial, we continually monitor the number and trend of events to ensure we have the most up-to-date perspective on when the trial will accrue the required number of events and allow us to lock the database. Since our last update, the pace of events has decreased, which is a common occurrence in this type of oncology study. We now expect top-line data from the LAPIS Phase 3 study of PamrevoMab and locally advanced unresectable pancreatic cancer in the third quarter of 2024, reflecting the current number and trend of overall survival events.

CFO: The primary endpoint is overall survival.

CFO: Given LAPIS is an event driven trial, we continually monitor the number and trend of events to ensure we have the most up to date perspective on when the trial will accrue the required number of events and allow us to lock the database.

Since our last update the pace of events has decreased which is a common occurrence in this type of oncology study.

CFO: We now expect top line data from the LAPIS Phase III study of <unk> in locally advanced Unresectable pancreatic cancer in the third quarter of 2024, reflecting the current number and trend of overall survival events.

Thane Wettig: Moving to slide 12, we show a snapshot of the 2-pound Revlimab registrational studies, which are being conducted in locally advanced and metastatic patients. These patients represent almost 90% of all diagnosed pancreatic cancer patients today, giving PamrevoMed the potential opportunity to treat a vast majority of patients across this devastating disease. One important difference between the two studies is the dosing regimen of the Precision Promise study. Pemrevonev is dosed in 28-day treatment cycles until disease progression or discontinuation, which is distinct from lapis, in which PamrevoMab was delivered in a neoadjuvant setting and where it was dosed for up to six months.

CFO: Moving to slide 12, we show a snapshot of the <unk> Registrational studies, which are being conducted in locally advanced and metastatic patients.

These patients represent almost 90% of all diagnosed pancreatic cancer patients today, given <unk> the potential opportunity to treat a vast majority of patients across this devastating disease.

CFO: One important difference between the two studies is the dosing regimen of the precision promise study.

CFO: <unk> is dosed in 28 day treatment cycles until disease progression or discontinuation.

CFO: Which is distinct from LAPIS in which <unk> was delivered in the neo adjuvant setting and where it was dosed for up to six months.

Thane Wettig: We believe the ability to dose patients until disease progression in the metastatic setting provides a potential opportunity to amplify clinically meaningful increases in overall survival driven by those patients benefiting from PEM Revlimab treatment. On slide 13, we review the U.S. commercial opportunity for PamrevoMab in pancreatic cancer. There have been limited treatment advances over the last two decades in both locally advanced and metastatic diseases, with immuno-oncology therapies providing benefit to a small subset of metastatic patients.

CFO: We believe the ability to dose patients until disease progression in the metastatic setting provides a potential opportunity to amplify clinically meaningful increases in overall survival driven by those patients benefiting from <unk> treatment.

CFO: On Slide 13, we review the U S commercial opportunity for <unk> in pancreatic cancer, there had been limited treatment advances over the last two decades in both locally advanced and metastatic diseases with immuno oncology therapies, providing benefit to a small subset of metastatic patients.

CFO: Using straightforward assumptions the total addressable market for pancreatic cancer in the U S represents a multibillion dollar opportunity for Perm rebel map if it can demonstrate a clinically meaningful improvement in overall survival in either locally advanced or metastatic patients.

CFO: Even modest penetration in either of these segments represents a substantial commercial opportunity in the U S alone.

CFO: Where fiber Gen plans to commercialize on its own should Pam <unk> game approval.

CFO: In summary, <unk>, if approved could represent a meaningful advance in prolonged survival for patients with pancreatic cancer and a game changing opportunity for fiber Jen we expect top line results in the near term.

CFO: Moving now to slide 15.

Thane Wettig: Roxadustat for Anemia of Chronic Kidney Disease continues to perform extremely well in China. First quarter total Roxyjuice net sales in China by FibroGen and the distribution entity jointly owned by FibroGen and AstraZeneca were $79.4 million compared to $64.1 million in the first quarter of 2023, an increase of 24%. This growth was driven by an increase in volume of 39%.

CFO: <unk> for anemia of chronic kidney disease continues to perform extremely well in China.

CFO: First quarter total rocks reduced that net sales in China by <unk> and the distribution entity jointly owned by <unk> and Astrazeneca was $79 4 million.

CFO: Compared to $64 1 million in the first quarter of 2023.

CFO: An increase of 24% this growth was driven by an increase in volume of 39%.

Thane Wettig: FibroGen's portion of Roxadustat net product revenue in China was $30.5 million for the first quarter on a U.S. gap basis, compared to $24.2 million in the first quarter of 2023, an increase of 26%. Moving to slide 16, Rasa Justet continues to expand its category leadership and brand value share in China, rising to 47% in the most recent three-month period ending in February of 2024. The potential addition of the chemotherapy-induced anemia indication would provide an important new treatment alternative for patients with chemotherapy-induced anemia and would be a meaningful addition to the ROXADUCE debt business in China.

CFO: The <unk> portion of <unk> net product revenue in China was $35 million for the first quarter on a U S GAAP basis.

CFO: Compared to $24 2 million in the first quarter of 2023, an increase of 26%.

CFO: Moving to slide 16 rocks reduced debt continues to expand its category leadership and brand value share in China rising to 47% in the most recent three month period ending in February of 2024.

CFO: The potential addition of the chemotherapy induced anemia indication would provide an important new treatment alternative for patients with chemotherapy induced anemia and be a meaningful addition to the <unk> business in China.

Thane Wettig: Given that there have been several generic applications filed in China, I would like to reiterate the dynamics of the generic market more broadly in China and the exclusivity of Roxadustat. The impact of a generic approval and launch in China is meaningfully different than in the U.S. market. Generic players face lead time and execution risk of market adoption after approval as they need to be admitted into hospital formularies one listing at a time.

CFO: Given that there have been several generic applications filed in China, I would like to reiterate the dynamics of the generic market more broadly in China and the exclusive exclusivity of <unk>.

CFO: The impact of a generic approval and launch in China is meaningfully different than in the U S market.

CFO: Generic players face lead time and execution risk of market adoption after approval as it needed to be admitted into hospital formularies, one listing at a time.

Thane Wettig: Originator products do not experience a meaningful deterioration in revenue until at least four generic products are approved. Even then, originator products in China have historically been able to maintain a stream of net revenues and profits after generics enter the market.

CFO: Originated products do not experience a meaningful deterioration in revenue until at least four generic products are approved.

CFO: Even then originated products in China have historically been able to maintain a stream of net revenues and profits after generics enter the market.

Thane Wettig: Despite the expiration of our Composition of Matter patents in June 2024, we do not expect meaningful deterioration of the ROC's two-step business in the near term. In addition to the continued outstanding performance of ROCS, as you said in China, Rock seduced at penetration in Europe continues to increase, showing strong quarter over quarter growth.

Despite the expiration of our composition of matter patents in June 2024.

CFO: We do not expect meaningful deterioration of the rocks do step business in the near term.

CFO: In addition to the continued outstanding performance of <unk> in China <unk>.

CFO: <unk> penetration in Europe continues to increase showing strong quarter over quarter growth.

Thane Wettig: We expect this growth to continue given the fact that Roxadustat is now fully reimbursed in all EU5 countries. Roxasucet is the only HIF-PHI indicated in the EU for the treatment of anemia of CKD in both non-dialysis and dialysis patients. And with GSK's decision to withdraw the MAA for Dapr-Dustat, RoxyDustat maintains its strong competitive position in the EU. Of note, we have recently been successful in defending our patent portfolio and now believe RoxyDustat has exclusivity into 2036, positioning it to continue its growth and hip market leadership over the next decade in the EU.

CFO: We expect this growth to continue given the fact that <unk> is now fully reimbursed in all EU five countries.

CFO: <unk> is the only <unk> indicated in the EU for the treatment of anemia of <unk> in both non dialysis and dialysis patients.

CFO: And with Gsk's decision to withdraw the MAA for DAP produced at <unk> that maintains its strong competitive position in the EU.

CFO: Of note we have recently been successful in defending <unk> patent portfolio and now believe <unk> reduced that has exclusivity into 2036 position and positioning it to continue its growth and hip market leadership over the next decade in the EU.

Thane Wettig: Moving to slide 17, earlier in the year, we announced that AstraZeneca returned all U.S. ROW rights for Roxasustat to FibroGen with the exception of South Korea. FibroGen's collaboration agreement with AstraZeneca for Roxasustat in China remains in place. Regaining the rights to Roxasducet in the U.S. allows us to pursue Roxasducet development opportunities with potential partners in indications such as anemia associated with lower risk myodysplastic syndrome. On slide 18, we highlight the potential opportunity for Roxidustat in patients with anemia associated with lower risk MDS.

CFO: Moving to slide 17 earlier in the year, we announced that Astrazeneca returned all U S RW rights.

CFO: <unk> just at two five region with the exception of South Korea, <unk> collaboration agreement with Astrazeneca for <unk> in China remains in place.

CFO: Regaining the restaurants do set in the U S allows us to pursue <unk> development opportunities with potential partners in indications such as anemia associated with lower risk lower risk Myelodysplastic syndrome.

CFO: On slide 18, we highlight the potential opportunity for <unk> in patients with anemia associated with lower risk Mds, there's a well defined patient population and a clear clinical need given the current therapeutic alternatives, which translates into a significant commercial opportunity we continue outreach to potential interested parties.

Thane Wettig: There is a well-defined patient population and a clear clinical need given the current therapeutic alternatives, which translates into a significant commercial opportunity. We continue outreach to potential interested parties. Moving on to slide 19. Late last year, we presented data from the Phase 3 Matterhorn study of rocks used in patients with anemia of lower risk myotisplastic syndrome at the American Society of Hematology annual meeting.

CFO: <unk>.

CFO: Moving on to Slide 19 late last year, we presented data from the phase III Matterhorn study <unk> in patients with anemia of lower risk Myelodysplastic syndrome at the American Society of Hematology annual meeting.

Thane Wettig: Although we missed the primary endpoint of transfusion independence driven by a high placebo response in patients with a low transfusion burden at baseline, Roxidustat demonstrated a numerical advantage relative to placebo. When looking specifically at results in patients with a higher transfusion burden at baseline, there was a statistically significant and clinically meaningful advantage in transfusion independence in patients treated with Roxidustat versus placebo. Based on these results, we continue to believe that Roxiducet represents an important potential therapy for patients in the U.S. and other territories where it has not yet been approved.

CFO: Although we missed the primary endpoint of transfusion independence, driven by a high placebo response in patients with low transfusion burden at baseline.

CFO: <unk> demonstrated a numerical advantage relative to placebo when looking specifically at results in patients with a higher transfusion burden at baseline there was a statistically significant and clinically meaningful advantage in transfusion independence in patients treated with <unk> versus placebo.

CFO: Based on these results we continue to believe that <unk> represents an important potential therapy for patients in the U S and other territories, where it has not yet been approved.

Thane Wettig: Lastly, in April, we announced compelling top-line results from our Phase 1 monotherapy study of FG3246 in patients with metastatic castration-resistant prostate cancer. Before I hand it over to Deyaa Adib, our new CMO, I would like to highlight the deep clinical development experience that Deyaa brings to FibroGen. He has over 28 years of biopharmaceutical drug development experience, including multiple global product submissions, approvals, and launches. Most importantly, Deyaa advances our capabilities in both pancreatic cancer and prostate cancer given his prior experience, and we are fortunate to have him leading the clinical development team. Deyaa, over to you.

CFO: Lastly in April we announced compelling top line results from our phase one monotherapy study of FG $32 46 in patients with metastatic castration resistant prostate cancer.

CFO: Before I hand, it over to Dave <unk>, our new CMO I would like to highlight the deep clinical development experience. The data brings to fiber Gen. He has over 28 years of Biopharma drug development experience, including multiple global product submissions approvals and launches.

CFO: Most importantly, the advances our capabilities in both pancreatic cancer and prostate cancer given his prior experiences and we are fortunate to have him leading the clinical development team data over to you.

Dave: Thank you <unk> before I begin.

Dave: Firstly.

Dave: I'm delighted to be part of the team here at <unk>.

Dave: Sure.

Speaker Change: I've been here for just over two months now.

Speaker Change: I'm very excited about the prospects of the company's innovative oncology pipeline.

Deyaa Adib: But that demonstrates a very limited expression in most normal tissues, making it an ideal ADC target candidate. FG3246 is comprised of an anti-CD46 antibody, YS5, linked to an antimyotic agent, MMAE, which is a clinically validated and FDA-approved ADC payload. On slide 22, we show that FG3246 has demonstrated efficacy against CD46-expressing tumors in both preclinical and clinical studies, and Associated Pets Imaging Biomarker, PET-46, utilizes the same targeting antibody as FG3246 and is under clinical development at UCSF. It is composed of the YS5 antibody coupled to the radionuclide zirconium 89 and, in preclinical studies, demonstrates specific targeting of and uptake by CD46 positive tumor cells.

Speaker Change: Moving to slide 21.

Speaker Change: <unk> hundred 46 is a first in class ADC for metastatic castration resistant prostate cancer colorectal cancer and other tumor types.

Speaker Change: FG $3 46 binds to a cell receptor target that internalizes upon antibody binding and is present in approximately 50% to 70% of prostate tumors.

Speaker Change: But that demonstrates the very limited expression in most normal tissue, making it an ideal ADC target candidate.

Speaker Change: <unk> hundred 46 is comprised of an anti CD 46 antibody <unk> five linked to an anti mitotic agent MMA, which is clinically validated and FDA approved ADC payloads.

Speaker Change: On slide 22, we show that the <unk> $32 46 has demonstrated efficacy against CD 46, expressing tumors in both preclinical and clinical studies.

Speaker Change: And associated pet imaging biomarker, but 46.

Speaker Change: Utilizes the same targeting antibody as FG $32 46, and is under clinical development at UCSF.

It is constituted of the wireless five antibody coupled to the radionuclide zirconium 89 and in preclinical studies demonstrate specific targeting.

Speaker Change: And uptake by CD 46 positive tumor cells.

Deyaa Adib: FG3246 has demonstrated monotherapy clinical efficacy in metastatic castration-resistant prostate cancer. Now, let's get into the top line results from the monotherapy phase one trial in MCRPC on slide 23. In the phase one dose escalation component of the study, those levels of FG3246 were administered in 21 day cycles. In the dose expansion arm of the trial, patients were treated at 2.7 mg per kg, adjusted body weight dosing to 100 kg, until disease progression or the occurrence of toxicity, for example, those limiting toxicity.

Speaker Change: FG, 30% to 46 has demonstrated monotherapy clinical efficacy in metastatic castration resistant prostate cancer.

Now, let's get into the top line results from the monotherapy phase one trial in.

Speaker Change: <unk> on slide 23.

Speaker Change: In the phase one dose escalation component of the study.

Speaker Change: Those levels of FG 3200, 46 were administered in 21 day cycles.

Deyaa Adib: The endpoints were safety, tolerability, and antitumor activity as measured by the decline of prostate specific antigen from baseline, objective tumor response rate in patients with measurable disease and radiographic progression, and free survival using the prostate cancer working group criteria for tumor response assessment. The completed phase one trial included a total of 56 peristaltic castration-resistant prostate cancer patients who were biomarker unselected and received a median of five prior lines of therapy before receiving FG3246.

Speaker Change: The endpoints for safety Tolerability and anti tumor activity as measured by the decline of prostate specific antigen from baseline objective tumor response rate in patients with measurable disease, and radiographic progression free survival using the prostate cancer working group criteria for.

Speaker Change: Tumor response assessment.

Speaker Change: The completed phase one trial includes a total of 56 metastatic castration resistant prostate cancer patients.

Speaker Change: Who are biomarker unselected and received immediate five prior lines of therapy before receiving <unk> $32 46.

Deyaa Adib: In the efficacy analysis population, we observed a median radiographic progression-free survival of 8.7 months. For Resist Evaluable Patients, 20% met the criteria of a partial response, or tumor reduction in size of at least 30% compared to baseline, with a median duration of response of 7.5 months. PSA reductions of at least 50% were observed in 36% of patients.

Speaker Change: And the efficacy analysis population, we observed immediate geographic progression free survival of eight seven months.

Speaker Change: <unk> assist evaluable patients, 20% met the criteria of a partial response or.

Speaker Change: Or tumor reduction in size of at least 30% compared to baseline.

Speaker Change: With a median duration of response of seven five months.

Speaker Change: <unk> reductions of at least 50% were observed in 36% of patients.

Deyaa Adib: FG3246 demonstrated an acceptable safety profile with adverse events consistent with those observed in other antibody drug conjugate therapies with an MMA payload. We look forward to publishing the totality of the Phase I data in a manuscript in the coming months as we advance the program further into the clinic. We are encouraged by these findings, and we believe a radiographic progression-free survival of 8.7 months is very compelling compared with existing standards of care in MCRPC settings.

Speaker Change: <unk> thousand 246 demonstrated.

<unk> safety profile with adverse events consistent with dealt with those observed in other anti body drug conjugate therapies within MMA payloads.

Speaker Change: We look forward to publishing the totality of the phase one data in a manuscript in the coming months as we advance the program further into the clinic.

Speaker Change: We believe that radiographic PFS is a mature clinically meaningful endpoints versus other early signals such as PSA 50, and objective response rate.

Speaker Change: Safe cancer.

Speaker Change: Moving to slide 24.

Deyaa Adib: There is also a combination trial with enzalutamide that is currently being run at UCSF. The rationale for this combination is based on preclinical data demonstrating upregulation of CD46 in tumor cells post-exposure to a second-generation Anderson receptor signaling inhibitor, therefore potentially sensitizing them to treatment with FG3246. I'm excited to remind everyone that we announced that interim data from the dose escalation portion of the study for FG3246 in combination with enzalutamide was selected for poster presentation at the 2024 American Society of Clinical Oncology annual meeting on June 2.

Speaker Change: There is also a combination trial with <unk>.

Speaker Change: That is currently being drawn at UCSF.

Speaker Change: The rationale for this combination is based on preclinical data demonstrating upregulation of <unk> 46 in tumor cells post exposure to a second generation androgen receptor signaling inhibitor, therefore, potentially sensitizing them to treatment with FG three to 46.

Speaker Change: Im excited to remind everyone.

Speaker Change: That we announced that interim data from the dose escalation portion of the study.

Speaker Change: For FG $3 46 in combination with <unk> was selected for poster presentation at the 2020 for American Society of clinical oncology annual meeting on June 2nd.

Deyaa Adib: Also, a trial for the PET-46 biomarker in prostate cancer is in progress at UCSF. The goal is to develop a screening assay to be able to select patients with high CD-46 expression who are most likely to benefit from treatment with FG-3246.

Also at trial for their pet 46 biomarker in prostate cancer is in progress at UCSF. The goal is to develop a screening assay to be able to select patients with high <unk> 46 expression, who are most likely to benefit from the treatment with FG three $2 46.

Deyaa Adib: The radiopharmaceutical biomarker will be part of our phase 2 dose optimization monotherapy trial sponsored by FibroGen. This could potentially enhance screening, patient selection, and enrichment, ensuring the proper selection of patients for the target to receive therapy and derive meaningful clinical benefits. Lastly, we are planning a meeting with the FDA in the third quarter to discuss the details of the FG3246 development program. Contingent upon reaching agreement with the FDA on the trial design, we anticipate the initiation of a phase 2, 3 dose optimization and registration enabling study in metastatic castration-resistant prostate cancer in the fourth quarter of 2024.

Speaker Change: The radiopharmaceutical biomarker will be part of our phase two dose optimization monotherapy trial sponsored by fiber churn.

Speaker Change: This could potentially enhanced screening patient selection and enrichment, ensuring the proper selection of patients for that target to receive therapy and drive meaningful clinical benefits. Lastly, we are planning a meeting with FDA in the third quarter to discuss the details of the F. G 30.

Speaker Change: 246 development program.

Speaker Change: Contingent upon reaching agreement with the FDA on the trial design.

Speaker Change: We anticipate the initiation of a phase III dose optimization and the registration enabling study in metastatic castration resistant prostate cancer in the fourth quarter of 2024.

Deyaa Adib: Moving to slide 25, we want to summarize the unique opportunity that FG3246 presents. FG3246 represents a novel mechanism of action and a first-in-class opportunity, pairing an antibody against a novel target with a validated chemotherapy payload.

Speaker Change: Finally, moving to slide 25.

Speaker Change: We want to summarize the unique opportunity that FG three to 46 presents.

Speaker Change: Sure.

Speaker Change: <unk> 32, 46 presents and novella mechanism of action and a first in class opportunity favoring an antibody against <unk> target with a validated chemotherapy payloads.

Deyaa Adib: FG3246, they offer treatment beyond prostate cancer, with potential applications in multiple lines of metastatic castration-resistant prostate cancer in combination with enzalutamide and other solid tumors such as colorectal cancer. FG3246 could potentially represent a paradigm shift in oncology, offering not only a novel mechanism of action but also promising efficacy, safety, and potential across various cancers. We look forward to updating you on FG32 I will now turn the call over to Juan to discuss the company's financials. Okay, Juan?

Speaker Change: <unk> hundred 46 may offer a treatment beyond prostate cancer.

Speaker Change: With potential applications in multiple lines of metastatic castration resistant prostate cancer in combination with <unk> and other solid tumors such as colorectal cancer.

Speaker Change: <unk> 3200, 46 could potentially represent a paradigm shift in oncology offering not only in novel mechanism of action, but also promising efficacy safety and potential across various cancer types.

Speaker Change: We look forward to updating you on <unk> $32 46, as the studies progress I will now turn the call over to Juan to discuss the company's financial fun.

Juan Graham: Thank you, Deyaa, and again, welcome to FibroGen. I will begin my remarks with a revenue summary for the first quarter of 2024, subsequently providing financial performance details on our China business for the quarter, along with 2024 guidance for our China operations. And finally, I will wrap up with OPEX results and our cash out. For the first quarter of 2024, total revenue was $55.9 million compared to $36.2 million for the same period in 2023, an increase of 55% year over year.

Juan: And again welcome to fiber Jim.

Juan Graham: The total revenue increase was driven by net product revenue in China and one-time drug product revenue recognized due to the termination of the U.S.-Rest of the World AstraZeneca Agreement. I will now provide further detail on... In the first quarter of 2024, we recorded $30.5 million of net product revenue for Roxadustat sales in China, compared to $24.2 million in the first quarter of 2023, representing an increase of 26% year over year. This increase was driven by a volume increase of 39% versus last year.

Juan: For the first quarter of 2024 total revenue was $55 9 million compared to $36 $2 million for the same period in 2023, an increase of 55% year over year.

Total revenue increase was driven by net product revenue in China.

Juan: And onetime drug product revenue recognized due to the termination of the U S rest of the World Astrazeneca agreement.

Juan: I will now provide further detail on revenue.

Juan: In the first quarter of 2024, we recorded $35 million of net product revenue for <unk> sales in China compared to $24 $2 million in the first quarter of 2023, representing.

Juan: Representing an increase of 26% year over year.

Juan: This increase was driven by a volume increase of 39% versus last year.

Juan Graham: Roxa D'Usta's performance in China continues to deliver strong results, and we are delighted by this continued growth. In Q1 2024, we recorded $0.9 million in development revenue compared to $3.9 million during the first quarter of 2023. Now that we have terminated the AstraZeneca-U.S. Rest of World Agreement, we expect our development revenue to decline in 2024 compared to last year. As we move forward, we expect quarterly development revenue to be below half a million dollars for the remainder of the year.

Juan: <unk> performance in China continues to deliver strong results and we are delighted by this continued growth.

Juan: In Q1, 2024, we recorded zero point $9 million in development revenue compared to $3 $9 million during the first quarter of 2023.

Juan: Now that we have terminated the Astrazeneca U S rest of World agreement, we expect our development revenue to decline in 2024 versus last year as.

Juan: As we move forward, we expect quarterly development revenue to be below half a million dollars for the remainder of the year.

Juan Graham: In Q1 2024, we recorded $24.5 million of drug product revenue compared to $2.1 million during the first quarter of 2023. As a result of the recent termination of our collaboration with AstraZeneca in the U.S. rest of the world territories, we recorded one-time drug product revenue of $25.7 million, partially offset by a reduction of $1.2 million for Roxodusta bulk drug products sold to our partner Astellas, primarily driven by the weakening of the Japanese yen in the quarter.

Juan: In Q1, 2024, we recorded $24 $5 million of drug product revenue compared to $2 1 million during the first quarter of 2023.

Juan: The weakening of the Japanese yen in the quarter.

Juan Graham: I will now move to provide further detail on our financial performance in China. As previously mentioned by Thane, total ROXADUCE.NET sales from the Joint Distribution Entity, or JDE, owned by AstraZeneca and FibroGen, was $79.4 million this quarter compared to $64.1 million in the first quarter of 2023, an increase of 24% year-over-year, highlighting the continued strong performance of the Avrenso franchise in China, while also achieving our highest value share since launch at 47% of the category.

Juan: I will now move to provide further detail on our financial performance in China.

As previously mentioned by pain total <unk> net sales from the joined distribution entity or J D. E owned by Astrazeneca and fiber, Jim was $79 $4 million this quarter compared to $64 1 million in the first quarter of 2023 and.

Juan Graham: From total Roxadusta net sales in China, FibroGen's net transfer price from sales to the JDE was $24.5 million for the first quarter, compared to $19.3 million in the first quarter of 2023, an increase of 27% year-over-year. The net transfer price is the best reflection of FibroGen's portion of the cash received from RoxaDustep in China. During this quarter, we also released $2.6 million from deferred revenue. As a result, FibroGen recorded $27.1 million of net revenue for the quarter from Ruxedusta sales to the JDE and $3.4 million of direct-to-distributor sales from FibroGen China, totaling $30.5 million on a U.S. gap basis.

An increase of 27% year over year.

Juan: Net transfer price is the best reflection of fiber <unk> portion of the cash received from <unk> in China.

Juan: During this quarter, we also released $2 $6 million from deferred revenue.

Juan: As a result fiber general recorded $27 1 million of net revenue for the quarter from <unk> sales to the J D E and $3 $4 million of direct to distributor sales from fiber in China totaling $35 million on a U S GAAP basis.

Juan Graham: Our revenue growth highlights the continuous robustness in execution and physician and patient adoption of Ruxidustat in China. For full year 2024, we are reiterating our forecast for FibroGen China product revenue to be between $120 to $135 million on a US GAAP basis, which assumes an underlying forecast of Ruxedusta net sales in China to range from $300 to $340 million. Now moving down the income statement, operating costs and expenses for the first quarter of 2024 were $87 million compared to $112.3 million for the first quarter of 2023, a decrease of $25.3 million or 23% year-over-year.

Juan: Our revenue growth highlights the continuous robustness in execution and physician and patient adoption of Brexit studying China.

Juan: For full year 2024, we are reiterating our forecast for fiber between China product revenue to be between $120 million to $135 million in U S. GAAP basis, which assumes an underlying forecast of <unk> net sales in China to range from $300 million to $340 million.

Juan Graham: Cost of goods sold for the first quarter of 2024 was $25.8 million, which included $21.1 million related to the AstraZeneca U.S. rest of the world revenue recognized as part of the termination agreement mentioned earlier. Excluding this one-time charge, our operating expenses came in below our total operating expense guidance, including cost of goods sold, of $70 to $80 million for the quarter.

Juan: Now moving down the income statement.

Juan: Operating costs and expenses for the first quarter of 2024 were $87 million compared to $112 $3 million for the first quarter of 2023.

Juan: A decrease of $25 $3 million or 23% year over year.

Juan: Cost of goods sold for the first quarter of 2024 was $25 $8 million, which includes $21 $1 million related to the Astrazeneca U S rest of the world revenue recognized as part of the termination agreement mentioned earlier.

Juan Graham: R&D expenses for the first quarter of 2024 were $38.4 million, compared to $74.5 million in the first quarter of 2023, a decrease of 48% or $36.1 million year-over-year, primarily reflecting reductions in preeminent clinical trial spend, as well as other R&D infrastructure. Of our $38.4 million in R&D expenses, approximately 56% was related to PEMRevolution. 37% allocated to support our early-stage pipeline, and the remaining 7% directed towards Ruxedusta development activities. SG&A expenses for the first quarter of 2024 were $22.8 million compared to $34.3 million in the first quarter of 2023, a decrease of 33.5% or $11.5 million year over year, primarily driven by the company's cost reduction efforts resulting in a leaner SG&A infrastructure.

Juan: R&D expenses for the first quarter of 2024 were $38 $4 million compared to $74 $5 million in the first quarter of 2023.

Juan: A decrease of 48% or $36 $1 million year over year, primarily reflecting reductions in <unk> clinical trial spend as well as other R&D infrastructure.

$438 $4 million in R&D expenses, approximately 56% was related to <unk>, 37% allocated to support our early stage pipeline and the remaining 7% directed towards development activities.

Juan: SG&A expenses for the first quarter of 2024 were $22 8 million compared to $34 $3 million in the first quarter of 2023 a.

Juan: A decrease of 33, 5% or $11 $5 million year over year.

Juan: Primarily driven by the car.

Juan: The company's cost reduction efforts, resulting in a leaner SG&A infrastructure.

Juan Graham: During the first quarter of 2024, we recorded a net loss of $32.9 million, or $0.33 per basic and diluted share, as compared to a net loss of $76.7 million, or $0.81 per basic and diluted share, for the first quarter of 2023. We reiterate our forecast of total operating expenses, including cost of goods sold, to be between $70 to $80 million for the second quarter of 2024. Our operating expenses in the second half of 2024 will be determined by the outcomes of our two pivotal clinical trial readouts for Pamrevlimab in pancreatic cancer. Now, shifting towards cash. As of March 31, we recorded $214.7 million in cash, cash equivalents, investments, and accounts receivable, with a reduction in operating expenses and maintaining a disciplined capital allocation approach.

Juan: We reiterate our forecast of total operating expenses, including cost of goods sold to be between $70 million to $80 million for the second quarter of 2024.

Juan: Our operating expenses in the second half of 2024 will be determined by the outcomes of our two pivotal clinical trial readouts for <unk> in pancreatic cancer.

Juan: Now shifting towards cash as of March 31, we recorded $214 $7 million in cash cash equivalents investments and accounts receivable.

Juan Graham: As previously communicated, we expect our cash, cash equivalents, investments, and accounts receivable to be sufficient to fund our operating plans into 2026. Thank you. And now I would like to turn the call back over to, Thank you Deyaa and Juan for your clinical and financial updates. In closing, we are excited about our near-term prospects and the potential value they provide to stakeholders. To recap, we expect top-line data from the following two time-level maps to be a pivotal study, our Phase 2-3 pancreatic cancer action network precision promise trial in metastatic pancreatic cancer in mid-2024, and the LAPIS Phase 3 trial in locally advanced pancreatic cancer in the third quarter of 2024.

Thank you and now I would like to turn the call back over to <unk>.

Speaker Change: Thank you David and one for your clinical and initial updates in closing we are excited about our near term prospects and the potential value. They provide the stakeholders to recap we expect topline data from the following two pivotal studies.

Speaker Change: Our phase III pancreatic cancer action network precision promise trial in metastatic pancreatic cancer in mid 2024.

Speaker Change: And the LAPIS phase III trial in locally advanced pancreatic cancer in the third quarter of 2024.

Speaker Change: <unk> continues to perform very well in China, where we expect an approval decision of our NDA for chemotherapy induced anemia indication.

Speaker Change: In the second half of this year and our partner ourselves continues to the commercialization of <unk> in Europe, Japan and other markets.

Speaker Change: Additionally, we are excited to regain rights for <unk> for U S. <unk> territories from AC and have been exploring potential partnering opportunities and anemia in patients with lower risk Mds.

Speaker Change: With our early stage pipeline, we recently reported compelling topline data from the phase one monotherapy study of FG $32 46 in metastatic castration resistant prostate cancer and we'll publish the totality of the phase one data in an upcoming manuscript.

We will be presenting top line data from the dose escalation phase <unk> study of FG $32 46 in combination with <unk> and <unk>.

NCR PC at the 2020 for American Society of clinical oncology annual meeting in June.

Speaker Change: We anticipate initiation of our phase II monotherapy dose optimization study of FG $32 46.

Speaker Change: <unk> in the second half of 2024.

Speaker Change: We anticipate FDA clearance of our IND for FG 3165, our anti <unk> antibody in the near term.

Speaker Change: And we anticipate filing an IND for FG $3 75, our anti <unk> antibody in 2025.

Speaker Change: Additionally, we have a strong balance sheet and expect our current cash position is one said to fund operations into 2026.

Thane Wettig: In summary, we will continue to execute against our strategic priorities as we strive to attain a valuation that we believe is more reflective of our current and future ROCS-induced debt revenue stream, near-term PAM rebel net readouts, pancreatic cancer, our oncology pipeline, and our strong balance. I would like to thank all the employees of FibroGen for their continued hard work and resilience over the last few months. I would now like to turn the call over to the operator of Q&A. Thank you. As a reminder, to ask a question, please press star 1 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 1 again.

Speaker Change: In summary, we will continue to execute against our strategic priorities as we strive to attain evaluation that we believe is more reflective of our current and future <unk> that revenue stream near term Pam rivaling that readouts in pancreatic cancer, our oncology pipeline and our strong balance sheet.

Operator: One moment for questions. Our first question comes from Andy Hesai with William Blair. You may proceed. Great, thanks for taking our questions and congratulations on the progress. So two quick ones and I have a follow-up. I'm pretty intrigued by your comment about slowing of the event rates as you wrap up the LAP study. Could you educate us on why that is?

Operator: Our first question comes from Andy <unk> with William Blair You May proceed.

Operator: Sure.

Andy: Great. Thanks for taking our questions and congratulations on the progress so.

Andy: Two quick ones and then I have a follow up.

Andy: And pretty intrigued by your comment about.

Andy: Slowing of the event rates as you wrap up the lap study could you educate us on why that is.

Andy Hesai: You know, in terms of, you know, factors kind of leading to the third quarter readout. And jumping back to Roxadustat, there's a nice uptick, as you mentioned, to 47% market value share. Can you also explain why that is?

Andy:

Andy: In terms of.

Andy: Factors leading to this.

Andy: Third quarter readout.

Andy: And jumping back to <unk>, there is a nice uptick as you mentioned a 47%.

Speaker Change: I guess.

Speaker Change: Market value share.

Andy Hesai: What's driving the uptick in uptake? Yeah, hey, Andy, thanks for your questions. On the lapis and the slowing event rate, you know, it's really just math. You know, we enrolled 284 patients. There are a certain number of OS events that need to be accrued to hit the pre-specified power that we had articulated in our SAP.

Speaker Change: Can you also explain.

Speaker Change: Why that is what's driving the uptick in <unk>.

Speaker Change: Jake.

Thane Wettig: And so as you accrue OS events, there are fewer patients to then accrue the remaining OS events. And that's where we are with that last part of the trial, where there are, thankfully, a number of patients who are still alive, but fewer patients to accrue these additional OS events. And it's just a common occurrence in an event-driven oncology trial or any event-driven trial of this type. And so, you know, like we said in our prepared remarks, we're looking every week at the number of OS events.

Jake: Hey, Andy Thanks for your questions on the the LAPIS and a slowing of event rate, yes, it's really just math.

Enrolled 284 patients.

Speaker Change: There are certain number of OS events that need to be accrued to hit the pre specified power that we had articulated in our SAP.

And so as you accrue OS events therapeutic fewer number of patients to then accrue the remaining OS events and Thats, where we are right.

Speaker Change: That last part of the trial, where there are thankfully a number of patients who are still alive, but fewer patients.

Thane Wettig: We're getting very close to that pre-specified number, and we'll continue to keep you updated on once we receive, on once we reach that number of OS events that reach then the pre-specified power that will allow us to then lock the database, perform the analysis, and then release top-line results. And as we said in the remarks, we expect that to be sometime in Q3. I would anticipate it to be earlier in Q3, but we wanted to say Q3 as opposed to Q2, which was the update last time, just to reflect the most recent trend of event rates. Does that make sense?

Speaker Change: To accrue these additional OS events, and it's just a common occurrence and an event driven oncology trial or any event driven trial.

Speaker Change: At this time and so.

Speaker Change: Like we said in our prepared remarks, we're looking every week at the number of OS events.

Speaker Change: We're getting very close to that pre specified number and we'll continue to keep you updated.

Speaker Change: Once we receive on once we reach that.

Speaker Change: That number of OS events that that reached the Prespecified power that will allow us to then.

Speaker Change: <unk> trend of event rates.

Thane Wettig: Yeah, that's very helpful. Thank you. Okay. And then, with respect to the 47% value share for Roxadustat, in addition, obviously, to the continued excellent execution by the AZ and China FibroGen teams, I'll turn it over to Chris for some additional comments. Hi, Andy. The local team is not really seeing any fundamental changes in market forces that would support this optimistic outlook. There are two factors that we can think of.

Speaker Change: That makes sense.

Speaker Change: Yes, that's very helpful. Thank you.

Speaker Change: Okay, and then with respect to the 47% value share for <unk>. In addition, obviously to the continued excellent execution by the AZ and fine up China fibers team I'll turn it over to Chris for some additional comments.

Speaker Change: Andy.

Chris: The local team is not really seeing any fundamental changes in market forces, but this optimistic outlook.

Chris: Two factors that we think can cause one.

Chris: And our deal price cuts that we experienced about 7%. So if you believe in price sensitivity.

Chris: That might have helped a little bit.

Chris: Second factor is.

Chris: Production of EMEA.

Chris: And Ron do stack, which we think.

Chris: Became a little bit of a second question for the class.

Chris: Because of that we have a installed base we have today.

Thane Wettig: We think it actually helped us a little bit. But overall, we remain optimistic about the market outlook, but we do not believe this reflects any fundamental change in the market outlook and forces. And I think, Andy, once you establish a momentum like Raksha D'Souza has done in China and you create this installed base of prescribers, this installed base of patients, and it gets on this momentum role like it's been on really since it launched.

Chris: Very small sales force, we think it actually helped us a little bit but overall, we remain optimistic about the market outlook, but we do not believe this reflects any fundamental change in the market outlook and voices.

Speaker Change: Thank you.

Speaker Change: You establish a momentum like the <unk> that is done in China and you create this installed base of prescribers this installed base of patients.

Speaker Change: It gets on this momentum role I can spin on really since it launched.

Thane Wettig: And the reason it's performing like that is because of the positive experience that it provides for patients and clinicians. And so it's just almost a self-perpetuating set of momentum that we expect to, you know, continue to see just because the drug performs extremely well at the patient level.

Speaker Change: And the reason, it's performing like that is because of the positive experience that is.

Speaker Change: It provides for patients and clinicians and so its just almost as a <unk>.

Speaker Change: Self perpetuating.

Speaker Change: Set of momentum.

Speaker Change: We expect to continue to see just because the drug performs extremely well at the patient level.

Andy Hesai: Thank you. Jumping to 3246, I guess, looking across the Paradigm for Prostate Cancer. Most of the options out there are monotherapies, I guess, with the exception of PARPs.

Speaker Change: Got it got it.

Speaker Change: That's helpful. Thank you.

Speaker Change: Jumping to $32 46.

Speaker Change: Looking across the <unk>.

Speaker Change: The paradigm for prostate cancer most of the options out there as monotherapy I guess with the exception of parks as you kind of think about the double of the <unk>.

Deyaa Adib: As you kind of think about the double of it, the indolutamine plus 3246 combination, in your discussions with the KLLs, what are they looking for? Just to kind of set up our expectations heading into the ASCO readout, is there like a bar for success in terms of PSA-50 reduction, PFS, or response rate based on resistance? Yeah, it's a great question, Andy.

Speaker Change: Dilutive mine plus $32 46 combination.

Speaker Change: In your discussions with the Kols.

Speaker Change: What are they looking for just kind of set up our expectations heading into the ask a readout is there like a bar for success in terms of P&L.

Speaker Change: PSA 50 reduction.

PFS or response rate based on the shift.

Yes, it's a great question and im going to turn it over to Dave for his thoughts.

Deyaa Adib: I'm going to turn it over to Deyaa for his thoughts. So, let me answer. Thank you for the question. First of all, it's a dose escalation study in combination with enzalutamide, and it will include the patient populations from the first first and second blind setting prior to receiving docetaxel in the MCRPC paradigm. So having said that, we are looking here to prove the hypothesis that patients who have been previously exposed to second generation ARSI are truly overexpressing CG46.

Dave: So let me answer. Thank you for the question first of all its a dose escalation study in combination with <unk>.

Dave: It will include the patient populations from the first first and second line setting.

Dave: Here to receiving docetaxel in the MCR EPC.

Dave: Paradigm, so having said that.

Dave: We are looking here to prove the hypothesis that patients who have been previously exposed to a second generation or a size.

Dave: Our truly over expressing CD 46. So this is what the objective of the trial.

Deyaa Adib: So this is what the objective of the trial is. Secondly, there has not yet been a threshold or a benchmark associated with the results because it's still a phase one escalation phase and will be followed by cohort expansion. So, based on what we see in terms of patient population first versus second line setting clinical benefits, we will be able to decide and discuss with KOLs what would be a clinically meaningful benefit, not just that.

Dave: Secondly, there has not been yet a threshold or a benchmark associated with the results because its still a phase one.

Dave: Galatian and will be followed by cohort expansion. So based on what we see in terms of patient population first versus second line setting.

Deyaa Adib: Also, what will be the threshold for radiographic progression-free survival, because this will be really the endpoint upon which we can start thinking about a registration path when we combine it with enzalutamide? Regarding PSA-50 or objective response rate, as you are aware, PSA-50 is a pharmacodynamic biomarker. It's an indication of clinical activity, but it's not a clear indication of how long patients will have disease-free survival or progression-free survival.

Dave: <unk> fast when we combined with <unk>.

Dave: Regarding PSA 50, or objective response rate as you are aware PSA 50 is a pharmacodynamic biomarker.

Dave: One indication of clinical activity, but it's not a clear indication for how long patients will have disease free survival or progression free survival.

Deyaa Adib: In terms of objective response rate, I also would like to remind you that it will pertain only to patients who have measurable disease at baseline, so we may see signals there, but remember that about 40% of patients with prostate cancer will show up with measurable disease, and 60% will show up with only bone lesions in the metastatic set. Okay. That's helpful context.

In terms of objective response rates I also would like to remind you. It will pertain only to patients who have measurable disease at baseline. So we may see signals, there, but remember that about 40% of patients with prostate cancer will show up with measurable disease, and 60% will show up with only.

Dave: Bone lesions in the metastatic setting.

Speaker Change: Got it that's helpful context. Thank you.

Andy Hesai: Thank you. Thank you. One moment for questions.

Speaker Change: Thank you.

Speaker Change: One moment for questions.

Jason Matthew Gerberry: Our next question comes from Jason Gerberry with Bank of America. You may proceed. Hi, good afternoon. This is Dina An for Jason. Congratulations on the progress this quarter and thank you for taking our question. Just one from us on FG3246.

Speaker Change: Our next question comes from Jason <unk> with Bank of America, You May proceed.

Dina: Could you just explain the reason for the Phase 2 dose optimization study that you're planning on initiating in the second half of this year? Like, is there more dose optimization necessary to supplement the Phase 1 data? Because it sounds like you're meeting with FDA ahead of, you know, kind of launching this Phase 2 trial. So, just curious how it will inform your Phase 2, 3, you know, registrational trial. Thank you. Yeah, it's a really good question, Dina.

Speaker Change: Hi, Good afternoon. This is dana on for Jason Congrats.

Dana: Congrats on the progress this quarter and thank you for taking our question.

Dana: Just one from us on.

Dana: FTE 30 to 46 could you just explain the reason for.

Dana: The phase two dose optimization study that youre planning on initiating in the second half of this year.

Dana: Is there more dose optimization necessary to supplement the phase one data.

It sounds like Youre meeting with FDA, you had a ahead of kind of watching to see two trials. So just curious how that'll inform your phase three registrational trial.

Speaker Change: Trial. Thank you.

Speaker Change: Yes, it's a really good question Dana thanks for that before I hand, it over today I'll stress that we have spent a lot of time thinking about what is the optimal design that not only will produce the clinical data that we believe will need to see but also will be done we'll do so in an efficient way given our competitive spaces.

Speaker Change: And I think it is.

Speaker Change: It's a <unk>.

Speaker Change: Estimates.

Speaker Change: And the experience that he brings not only in terms of overall clinical development experience, but also in the prostate cancer space. So let me turn it over to him and have him kind of walk you through our thinking and again.

Speaker Change: This is pending alignment with the FDA once we do meet with them, but it will provide a little bit more guidance in terms of <unk>.

Deyaa Adib: So let me turn it over to him and have him kind of walk you through our thinking. And again, this is pending alignment with the FDA once we do meet with them, but he'll provide a little bit more guidance in terms of, you know, why we think the way we think. Thank you, Thane. So to answer your question, the purpose of having this phase two component of the phase two-three design is to further optimize the dose that will be later on called the recommended phase three dose.

Speaker Change: Why were thinking the way we are thinking.

Speaker Change: Thank you Tim So to answer your question the purpose of having this phase II component of the phase III design is to further optimize the dose that will be later on calls the recommended phase II dose and this is essentially if you go backwards in 2023, the FDA has any.

Deyaa Adib: And this is essentially, if you go back to 2023, the FDA initiated Project Optimist, and it goes across the board in drug development to ensure that sponsors have identified the right dose moving forward that will offer patients maximum clinical benefit with the lowest risk in terms of adverse events. So we are essentially complying with the FDA requirements to optimize the dose before we start the phase three registration trial. So this is our thinking about dose optimization.

<unk> project Optimus and it grows across the board in drug development to ensure that sponsors have identified the right dose moving forwards that will offer patients maximum clinical benefit with the lowest risk in terms of adverse events. So we are essentially.

Speaker Change: Complying with the FDA requirements to optimize the dose and before we start the phase III registration trial. So this is our thinking about those.

Deyaa Adib: And then one final comment, Dean, in addition to what Deyaa articulated, we also plan on, again, pending concordance with the FDA, treating all the patients in this dose optimization phase with the PET-46 biomarker as well and then doing a post hoc analysis to assess the correlation of CD46 expression and response to the ADC. And so that's also an important component of the dose optimization part of the ongoing design. I got it.

Speaker Change: Those optimization.

Speaker Change: And then one final comment Deane in addition to what data articulated as we also plan on again pending <unk>.

Speaker Change: <unk> with the FDA plan on treating all of the patients in this dose optimization phase.

Speaker Change: Got it thank you so much.

Speaker Change: Sure.

Speaker Change: Thank you.

Deyaa Adib: Thank you so much. Thank you. One moment for questions. Our next question comes from Paul Choi with Goldman Sachs. You may proceed. Just to follow up on the prior question with regard to the Phase II monotherapy dose optimization, your timeline calls for data potentially in 2026. I'm just curious if there's anything in terms of your insight from the monotherapy portion, particularly at the higher doses, that might be able to accelerate that timeline for the Phase II dose optimization. My second question is just with regard to Evrenzo in China.

Speaker Change: One moment for questions.

Speaker Change: Our next question comes from Paul Choi with Goldman Sachs. You May proceed.

Paul Choi: You've maintained your updated timing for the CIA indication for the second half of this year, but just to confirm, your expectation for inclusion into NRDL would be no earlier than calendar 2026. If you could confirm that, that'd be great. Thank you. Thanks, Paul. Regarding the kind of 2026 timeline for FG3246, you know, now that we've taken a step back and that we've done a lot more thinking around this proposed phase two slash three design that we will discuss with the FDA, it's probably a bit premature to talk about when we would see the totality of that dose optimization data set.

Paul Choi: Hi, Thank you good afternoon, and thank you for taking our questions.

Paul Choi: Just to follow up on the prior question with regards to the phase II monotherapy dose optimization.

Your timeline calls for.

Paul Choi: Potentially in 2020, I'm just curious if theres anything in terms of your insight from the monotherapy portion in particular at the higher doses that might be able to accelerate that timeline for the phase two dose optimization.

Paul Choi: My second question is just with regard to.

Paul Choi: Our friends and <unk>.

Paul Choi: China.

Paul Choi: You've maintained your updated timing for the <unk>.

Speaker Change: Yes, thanks, Paul regarding the that kind of a 2026 timeline for FG three to $2 46, now that we've taken a step back and that we've done a lot more thinking around this proposed phase II <unk> III design that we will discuss with the FDA, it's probably premature to talk about when we.

Speaker Change: See the totality of that dose optimization dataset, our goal would be to get this trial started as quickly as we can after discussion with the FDA in alignment with them and then begin execution. We think it will be a it has the potential to be a rapidly enrolling trial is not a.

Paul Choi: You know, our goal would be to get this trial started as quickly as we can after discussion with the FDA and alignment with them. And then, you know, begin execution. We think it will be a, has the potential to be, a rapidly enrolling trial. It's not a huge cohort of patients in this dose optimization phase. And so our plan would be to get to execution as quickly as we possibly can. Deyaa, would you add anything to that?

Speaker Change: Huge cohort of patients in this dose optimization phase and so our plan would be to get to execution as quickly as we possibly can.

Thane Wettig: No, to your point, Dane, this will be a data-driven study, and it will inform us in terms of not only dose optimization or the recommended phase three dose, but also enable us to select the patients who will get the best clinical benefit out of this ADC going into the phase three component of the trial. Yeah, and then Paul, I'll ask Chris to comment on the updated CIA timing guide. So, Paul, we updated the timing of the projected approval timeframe based on the current progress at the CD in the review of the technical filing.

Speaker Change: Add anything to that.

Speaker Change: To your point <unk>. This will be a data driven study and it will inform us in terms of not only those optimization or the recommended phase II dose, but also enabling us to select the patients who will make the best clinical benefit out of this ADC going into the phase III component of the trial.

Speaker Change: And then.

Speaker Change: Paul ask Chris to comment on the updated CIA timing guidance.

Chris: So Paul we updated the timing of the.

Paul Choi: The projected approval timeframe based on the current progress of the TB a review of the technical filing we are projecting a second half 2024, although right now we're not in a position to comment on the regulatory review process, but to be conservative we moved it to second half.

Thane Wettig: We are projecting a second half of 2024, although right now we're not in a position to comment on the regulatory review process, but to be conservative, we moved it to the second half. To answer your specific question, would that mean that we would not have reimbursement for the indication of CIA until January 1st, 2026? The answer is yes. In order for us to qualify for NLDL starting January 1st, 2025, we would need to be approved by 2024, June 30.

Paul Choi: To answer your specific question would that mean that we would not have reimbursement for the indication of CIA until January one 2026. The answer is yes in order for us to qualify for an RTL starting January one 2025, we would need to be approved by 2024 June 30th.

Speaker Change: Okay, great. Thank you.

Christine L. Chung: Okay, great. Thank you. Yeah, and so Paul, you know, we do believe that there's still a chance to, you know, hit the approval timing that would allow us to have in our deal inclusion for the CIA indication in 2025. And so the team continues to work, you know, very closely with the CDE on the review. It's just premature at this point in time to be able to handicap whether or not we'll be able to achieve that.

Speaker Change: And so Paul we do believe that there's still a chance to hit the the.

Speaker Change: The approval timing that would allow us to have in our deal inclusion for the CIA indication in 2025, right and so the team continues to work very closely with the CD dirt on the review, it's just premature at this point in time to be able to handicap, whether or not we'll be we'll be able to achieve that but.

Speaker Change: Please note that it is a really important goal for us.

Thane Wettig: But, you know, please know that it's a really important goal for us. Okay, great. Thanks for clarifying that. Thank you. Thank you. I would now like to turn the call back over to Thane Wettig for any closing remarks. Yeah, guys, we appreciate your participation in today's investor call and your continued interest in FibroGen. And thank you for the questions. Enjoy the rest of your day. Thank you. This concludes the conference. Thank you for your participation. You may now disconnect.

Okay, great. Thanks for clarifying that thank you.

Speaker Change: Thank you I would now like to turn the call back over to <unk> for any closing remarks.

Speaker Change: Yes, guys. We appreciate your participation in today's Investor call and your continued interest in fiber and then thank you for the questions enjoy the rest of your day.

Thank you. This concludes the conference. Thank you for your participation you may now disconnect.

Q1 2024 FibroGen Inc Earnings Call

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