Q4 2023 FibroGen Inc Earnings Call

Yeah.

Operator: Thank you for standing by, and welcome to FibroGen's fourth quarter and full year 2023 earnings conference call. At this time, all participants are in a listen-only mode.

Speaker Change: Thank you for standing by and welcome to fiber Jones fourth quarter and full year 2023 earnings conference call.

Speaker Change: At this time all participants are in a listen only mode.

Operator: After the speaker's presentations, there will be a question and answer session. To enter a question at that time, please press star 1 1 on your telephone. Please be advised that today's call is being recorded. I would like to turn the call over to your host, Mr. David DeLaChia, Vice President of Investor Relations. Please go ahead.

Speaker Change: After the Speakers' presentation there'll be a question and answer session to enter a question at that time. Please press star one on your telephone.

Speaker Change: Please be advised that today's call is being recorded.

Speaker Change: I would like to turn the call over to your host Mr. David David Shea.

David Shea: Vice President of Investor Relations. Please go ahead.

David DeLaChia: Good afternoon, everyone. Thank you for joining us today to discuss our fourth quarter and year-end 2023 financial and business results. I'm David DeLaChia, Vice President of Corporate FP&A and Investor Relations at FibroGen. Joining me on today's call are Sane Wettick, our Chief Executive 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 Shea: Good afternoon, everyone.

David Shea: Thank you for joining us today to discuss our fourth quarter and year end 2023 financial and business results I'm, David though a chair vice president of corporate F. DNA in Investor Relations at fiber John joining me on today's call are saying, what our Chief Executive Officer.

Sang: Graham our Chief Financial Officer, Dr. John Hunter, Our Chief Scientific Officer, and Chris Chung, Our senior Vice President of China operations.

Sang: 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 jobs.

David DeLaChia: 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.

Sang: 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.

Sang: Our regulatory strategies and potential regulatory results.

Sang: Our research and development activities.

Sang: 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 or events to differ materially from those projected in that statement a more complete description of these and other material risks can be found in fiber dense filings with the SEC.

David DeLaChia: 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 investor section of FibroGen's website at www.fibrogen.com. With that, I would like to turn the call over to Thane Wedeck, our Chief Executive Officer. Thank you, Dave.

Sang: SEC, including our most recent Form 10-K and Form 10-Q.

<unk> does not undertake any obligation to update publicly any forward looking statements, whether as a result of new information future events or otherwise a 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 fiber Jones website at Www Dot fiber Gen dotcom.

Speaker Change: With that I would like to turn the call over to <unk>, Our Chief Executive Officer.

Sang: Yeah.

Speaker Change: Thank you Dave Good afternoon, everyone and welcome to our fourth quarter and year end 2023 earnings call.

Thane Wedeck: Good afternoon, everyone, and welcome to our fourth quarter and year-end 2023 earnings call. Although 2023 posed numerous challenges for our organization, we are excited about our prospects in 2024, which we believe will be a pivotal year marked by a number of important clinical readouts across our oncology pipeline and continued growth of our Roxas-Dewstadt franchise. On today's call, I will focus our stakeholders on the four strategic pillars shaping our company's future trajectory.

Speaker Change: Although 2023 posed numerous challenges for our organization. We are excited about our prospects in 2024, which we believe to be a pivotal year marked by a number of important clinical readouts across our oncology pipeline and continued growth of our <unk> franchise.

Speaker Change: On today's call I will focus our stakeholders on the four strategic pillars shaping our company's future trajectory. Additionally.

Thane Wedeck: Additionally, I'll offer insights into the progress of our PemRevelMab and Rox2STAT programs. Dr. John Hunter, our Chief Scientific Officer, will then review our exciting oncology pipeline. Last, Juan Graham, our CFO, will review the financials, after which we will open the call to your questions.

Speaker Change: Additionally, our offer insights into the progress of our Pam rebel Mab and rocks do step programs, Dr. John Hunter, Our Chief Scientific Officer will then review our exciting oncology pipeline last one Gram our CFO will review the financials after which we will open the call for your questions.

Thane Wedeck: Starting on slide three, FibroGen has four key strategic pillars that we believe offer significant value today versus Pam Revlimab, where we are expecting readouts from two pivotal phase three studies in pancreatic cancer in the coming months. In January, we announced the graduation and completion of the PAMREVELMAB arm in Precision Promise, the Pancreatic Cancer Action Network's Phase 2-3 Adaptive Platform Trial for Metastatic Pancreatic Cancer, where we anticipate top-line data in the second quarter of this year. We are now anticipating top-line data from our ongoing LAPIS Phase 3 trial in locally advanced pancreatic cancer in the second quarter of 2024 as well. Pancreatic cancer is a disease with substantial unmet medical need and represents a significant commercial opportunity for PAM Revlimab, which has demonstrated effectiveness in both preclinical and early clinical studies, which we will detail in a moment. Second, is Roxadustat.

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

Speaker Change: First as Pam rebel map, where we are expecting readouts from two pivotal phase III studies in pancreatic cancer in the coming months and.

Speaker Change: In January we announced the graduation and completion of the <unk> arm and precision promise pancreatic cancer action network space two three adaptive platform trial for metastatic pancreatic cancer, where we are where we anticipate topline data in the second quarter of this year.

Speaker Change: We are now anticipating topline data from our ongoing LAPIS phase III trial in locally advanced pancreatic cancer in the second quarter of 2024 as well.

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

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

Thane Wedeck: Roxadustat is approved in over 40 countries, generates significant net revenue and positive cash flow, and provides FibroGen with material and growing profits through our partnerships with AstraZeneca and Astellas Pharma. Today, we announce that FibroGen has regained the rights to Roxidustat from our partner, AstraZeneca, in the U.S. and ROW territories, excluding China and South Korea. This allows us the opportunity to potentially partner Roxidustat in certain indications with high-end met needs, such as anemia and myodysplastic syndromes, which I will touch on later in the call. Third, we have an early stage oncology pipeline. We are very excited about the potential of these programs.

Speaker Change: Today, we announced that fiber Gen has regained the rights to <unk> from our partner Astrazeneca in the U S. In <unk> territories, excluding China and South Korea. This allows us the opportunity to potentially partner <unk> in certain indications with high unmet needs such as anemia in Myelodysplastic syndromes, which I will.

Speaker Change: Touch on later in the call.

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

Speaker Change: FG $32 46 is a first in class potent antibody drug conjugate or ADC for the treatment of metastatic castrate resistant prostate cancer.

Thane Wedeck: FG-3246 is a first-in-class potent antibody drug conjugate, or ADC, for the treatment of metastatic castrate-resistant prostate cancer. This program also includes the development of an associated CD46 targeted pet biomarker. We anticipate releasing additional data from our FG3246 Phase 1 monotherapy trial in the coming week. In addition to FG3246, we are also undertaking IND-enabling activities on two innovative oncology antibodies with the intention of filing an IND for FG3165, our anti-collectin 9 monoclonal antibody, in the first quarter of 2024 and FG3175, our anti-CCR8 monoclonal antibody, in 2025. The fourth pillar is our strong cash position. We finished the year with approximately $248.1 million in cash, cash equivalents, and accounts receivable.

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

Speaker Change: We anticipate releasing additional data from our <unk> $32 46 phase one monotherapy trial in the coming weeks. In addition to FG $32 46, we're also undertaking IND, enabling activities on two innovative oncology antibodies with the intention of filing an IND for.

Speaker Change: <unk> <unk> 31, 65, our anti collected nine monoclonal antibody in the first quarter of 2024, and FG 31, 75, our anti <unk> monoclonal antibody in 2025.

The fourth pillar is our strong cash position, we finished the year with approximately $248 1 million in cash cash equivalents and accounts receivable.

Speaker Change: In the fourth quarter, one quarter earlier than expected, we successfully executed on our company wide cost reduction plan, which.

Speaker Change: Which provides us with the ability to achieve several key milestones across our portfolio.

We have taken the necessary steps to improve our strong financial position and we will continue to focus on financial discipline.

Speaker Change: 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 <unk>. We believe that we have a strong foundation to drive significant shareholder value create.

Thane Wedeck: In the fourth quarter, one quarter earlier than expected, we successfully executed on our company-wide cost reduction plan, which provides us with the ability to achieve several key milestones across our portfolio. We have taken the necessary steps to improve our strong financial position and will continue to focus on financial discipline. 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. Moving to slide 5, Pamrevelmeb is a novel anti-CTGF human monoclonal antibody in clinical development for the treatment of metastatic pancreatic cancer and locally advanced unrespectable pancreatic cancer or LAPC.

Speaker Change: <unk> today and into the future.

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 adverse event and safety profile.

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

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%.

Speaker Change: Unfortunately, there have not been any major therapy therapeutic advances for quite some time.

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

Thane Wedeck: 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 adverse event and safety profile. I would now like to discuss the PAM-Revlimab opportunity in pancreatic cancer in more detail, starting on slide 6. 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. There is an overall five-year disease-free survival rate of only 12.5 percent.

Based on preclinical data CTG plays an important role in the growth and progression to pancreatic tumors.

Speaker Change: <unk> pancreatic tumor studies have shown that <unk> 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 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.

Speaker Change: 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 Gemcitabine and there are lots of nib as first line therapy.

Thane Wedeck: 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 PAM Revlimab can provide benefits to patients diagnosed with pancreatic cancer. Based on preclinical data, CTGF plays an important role in the growth and progression of pancreatic tumors.

Speaker Change: 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 the most notable results. In this study was that one year survival was 37% for patients who.

Speaker Change: We had circulating <unk> levels of 150 micrograms per ml or higher versus 11% for those with lower plasma levels.

Thane Wedeck: Mouse pancreatic tumor studies have shown that PamrevoMap 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 8, 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. Almost 90% of these 75 patients were in fact metastatic, with only nine having locally advanced disease.

Speaker Change: These results in the higher dose cohort patients included improved median overall survival and improved median progression free survival.

Speaker Change: Moving to slide nine pivotal trials are being conducted with Perm rebel map in both locally advanced and metastatic patients.

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

Speaker Change: Moving to slide 10.

Speaker Change: In January we announced the completion of the <unk> arm and precision promise pancreatic cancer action network's phase two three adaptive platform trial for metastatic pancreatic cancer, which evaluates <unk> in combination with the chemotherapy treatments gemcitabine and Nab paclitaxel for patients with metastatic pancreatic.

Thane Wedeck: Penrevimab 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.

Speaker Change: Ductal adenocarcinoma.

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

Speaker Change: The primary endpoint of the precision promise trial is overall survival.

Speaker Change: <unk> is being evaluated in both first and second line therapy for metastatic disease.

Thane Wedeck: The most notable result in this study was that one-year survival was 37 percent for patients who had circulating paramebromab levels of 150 micrograms per mL or higher versus 11 percent for those with lower plasma levels. These results in the higher dose cohort patients included improved median overall survival and improved median progression-free survival. Moving to slide 9.

Speaker Change: Moving to slide 11.

Speaker Change: The precision promise study is comprised of two stages.

Speaker Change: In the initial stage of the study or stage, one at least 100 patients with metastatic pancreatic cancer receive <unk> in combination with Gemcitabine and Nab Paclitaxel.

Speaker Change: Guided by Bayesian principles, the graduation threshold for Pam rebel map was a protocol pre specified greater than or equal to 35% predicted probability of success for the primary endpoint of overall survival at the completion of the trial.

Thane Wedeck: Pivotal trials are being conducted with pemRevlimab in both locally advanced and metastatic patients. These patients represent almost 90% of all diagnosed pancreatic cancer patients today, giving PAMREVOMAB the potential opportunity to treat a vast majority of patients across this devastating disease. Moving to slide 10.

Speaker Change: The <unk> arm successfully graduated to stage two in the third quarter of 2022, and an additional 75 patients were enrolled receiving the same Pam rebel Mab treatment regiment as in stage one.

Speaker Change: All patients were dosed until disease progression in the final analysis is based upon the data collected for all patients up to 12 months after the last patient initiated treatments.

Thane Wedeck: In January, we announced the completion of the PAM Revlimab arm in Precision Promise, the Pancreatic Cancer Action Network's Phase 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. The PRECISION PROMISE trial is a Phase 2-3 registrational study that is being conducted at the top pancreatic cancer centers in the United States. The primary endpoint of the Precision Promise trial is overall survival. PAM Revlimab is being evaluated as both first and second line therapy for metastatic disease. Moving to slide 11.

Speaker Change: The <unk> arm of the study completed stage two of the trial last month in January of 2024.

Speaker Change: <unk> is the first experimental arm and the precision promise trial to meet this required threshold for graduation to stage two and we now expect to report top line data on 213, <unk> treated metastatic pancreatic cancer patients next quarter.

Speaker Change: On slide 12.

Speaker Change: We provide an overview of the global phase III LAPIS trial at.

Speaker Change: A double blind placebo controlled trial in 284 patients with locally advanced Unresectable pancreatic cancer.

Speaker Change: Comparing <unk> to placebo in combination with standard of care chemotherapy.

Speaker Change: Primary endpoint is overall survival and we now expect top line data from this study in the second quarter of 2024.

Speaker Change: As LAPIS is an event driven trial, we have revised our timing based upon the latest information available to us.

Thane Wedeck: The Precision Promise Study is comprised of two stages. In the initial stage of the study, or stage one, at least 100 patients with metastatic pancreatic cancer received Pemrevomab in combination with gemcitabine and nabpaclitaxel. Guided by Bayesian principles, the graduation threshold for PAM-Revlimab 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 PAM-Revlimab arm successfully graduated to stage 2 in the third quarter of 2022, and an additional 75 patients were enrolled, receiving the same PAM-Revlimab treatment regimen as 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.

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

Speaker Change: We are currently waiting for a sufficient number of events to lock the database and we will continue to provide regular updates to our stakeholders as the study nears completion.

Speaker Change: Moving to slide 13.

Speaker Change: So a snapshot about Pam rebel Mab Registrational phase III studies.

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, which is distinct from LAPIS and which Pam <unk> was delivered in the neo adjuvant setting and where it was dosed for up to six months, we believe the ability to dose patients until disease progression in the metastatic setting provides the potential opportunity to amplify.

Speaker Change: Clinically meaningful increases in overall survival driven by those patients benefiting from <unk> treatment.

Speaker Change: On Slide 14, we review the U S commercial opportunity for <unk> in pancreatic cancer.

Speaker Change: 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.

Thane Wedeck: The Pam Revlimab arm of the study completed stage two of the trial last month in January of 2024. PAMREVIMAB is the first experimental arm in the PRECISION PROMISE trial to meet its required threshold for graduation to Stage 2, and we now expect to report top-line data on 213 PAMREVIMAB-treated metastatic pancreatic cancer patients next quarter. On slide 12.

Using straightforward assumptions the total addressable market for pancreatic cancer in the U S represents a multibillion dollar opportunity for <unk>. If it can demonstrate a significant improvement in overall survival and either locally advanced or metastatic patients.

Speaker Change: Fact, metastatic pancreatic cancer alone represents a larger market opportunity in the U S for Perm rebel Mab than we were previously forecasting for the IPF indication.

Speaker Change: Looking ahead, we expect results from both the pancreatic cancer action networks precision promise Registrational adaptive platform trial evaluating <unk> in metastatic pancreatic cancer and from the LAPIS Phase III study in locally advanced disease in the second quarter of 2024.

Thane Wedeck: 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 PamrevoMab to placebo in combination with standard of care chemotherapy. The primary endpoint is overall survival, and we now expect top-line data from the study in the second quarter of 2024. As LAPIS is an event-driven trial, we have revised our timing based upon the latest information available to us. Since our last update, the pace of events has decreased, which is a common occurrence in this type of oncology study. We are currently waiting for a sufficient number of events to lock the database and will continue to provide regular updates to our stakeholders as the study nears completion. Moving to slide 13, we show a snapshot of both Pam Revlimab registrational phase 3 studies. One important difference between the two studies is the dosing regimen of the PRECISION PROMISE study. Pemrevomab is dosed in 28-day treatment cycles until disease progression or discontinuation, which is distinct from lapis, in which Pemrevomab was delivered in a neoadjuvant setting and where it was dosed for up to six months.

Speaker Change: Moving now to <unk> on slide 16.

Speaker Change: <unk> continues to perform extremely well in China, whereas it where it is indicated for anemia of chronic kidney disease.

Speaker Change: Full year 2023, total <unk> net sales in China.

Speaker Change: <unk> <unk> and the distribution entity jointly owned by fibers and Astrazeneca was $284 1 million compared to $208 8 million a year ago, an increase of 36%. This growth was driven by an increase in volume of 41%.

Speaker Change: Fourth quarter total <unk> net sales in China by <unk> and the distribution entity jointly owned by fiber Gen Z was $66 5 million compared.

Speaker Change: Compared to $53 1 million in the fourth quarter of 2022, an increase of 25%. This growth was driven by an increase in volume of 36%.

Speaker Change: In July of 2023, our supplemental new drug application for <unk> in patients with chemotherapy induced anemia was accepted by the China Health Authority and we continue to expect an approval decision in mid 2024.

Speaker Change: If approved <unk>.

Speaker Change: <unk> would receive a $10 million milestone payment from Astrazeneca.

Thane Wedeck: We believe the ability to dose patients until disease progression in the metastatic setting provides the potential opportunity to amplify clinically meaningful increases in overall survival driven by those patients benefiting from PAM-Revlimab treatment. On slide 14, we review the U.S. commercial opportunity for pemrevimab and 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 this indication represents a meaningful incremental net revenue opportunity on top of the anemia of <unk> indication.

Speaker Change: Moving to slide 17.

Speaker Change: <unk> continues to expand as category leadership and brand value share in China.

Speaker Change: Risen to 42% in the most recent three month period ending in December of 2023.

The potential addition of the chemotherapy induced anemia indication would create a meaningful catalyst to both continued share and volume growth of <unk> 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 exclusivity of <unk>.

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

Speaker Change: <unk> Erik players face lead time and execution risk of market adoption after approval.

Thane Wedeck: Using straightforward assumptions, the total addressable market for pancreatic cancer in the U.S. represents a multi-billion dollar opportunity for pem-revo-mab if it can demonstrate a significant improvement in overall survival in either locally advanced or metastatic patients. In fact, metastatic pancreatic cancer alone represents a larger market opportunity in the U.S. for PAM-Revlimab than we were previously forecasting for the Looking ahead, we expect results from both the Pancreatic Cancer Action Network's Precision Promise Registrational Adaptive Platform Trial evaluating pem-revo-mab and metastatic pancreatic cancer and from the LAPIS Phase III study in locally advanced disease in the second quarter of 2024. Moving now to Roxa-Dustat, on slide 16.

Speaker Change: They need to be admitted into individual 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.

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

We do not expect meaningful deterioration of the rocks a business in the near term.

Speaker Change: In addition to the continued outstanding performance of <unk> in China. The rocks just at launch in Europe is accelerated showing robust quarter over quarter growth.

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

Thane Wedeck: Roxas Justec continues to perform extremely well in China, where it is indicated for anemia of chronic kidney disease. Full year 2023 total Roxydustat net sales in China by FibroGen and the distribution entity jointly owned by FibroGen and AstraZeneca were $284.1 million compared to $208.8 million a year ago, an increase of 36 percent. This growth was driven by an increase in volume of 41 percent.

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

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

Of note we have recently been successful in defending <unk> patent portfolio and now believe we have exclusivity into 2036 positioning <unk> to continue its growth and market leadership.

Speaker Change: The next decade, plus in the EU.

Speaker Change: Moving to slide 18 today, we announced that Astrazeneca returned all U S. <unk> rights to <unk> with the exception of South Korea and China.

Thane Wedeck: Fourth quarter total ROXADUCE net sales in China by FibroGen and the distribution entity jointly owned by FibroGen-NAZ were $66.5 million, compared to $53.1 million in the fourth quarter of 2022, an increase of 25%. This growth was driven by an increase in volume of 36%. In July 2023, our supplemental new drug application for Baroxidustat in patients with chemotherapy-induced anemia was accepted by the China Health Authority, and we continue to expect an approval decision in mid-2024. If approved, FibroGen would receive a $10 million milestone payment from AstraZeneca. We believe this indication represents a meaningful incremental net revenue opportunity on top of the anemia of CKD indication. Moving to slide 17.

Speaker Change: <unk> collaboration agreement with Astrazeneca for <unk> in China remains in place.

Speaker Change: Regaining the rights to <unk> in the U S. R O W territories.

Speaker Change: Laos us to pursue <unk> development opportunities with potential partners in indications such as anemia associated with Myelodysplastic syndromes.

Speaker Change: On slide 19, we highlight the potential opportunity for <unk> in patients with anemia associated with Mds.

Speaker Change: There is a well defined patient population and a clear clinical need given the current therapeutic alternatives, which translates into a significant significant commercial opportunity.

We look forward to initiating partnership discussions for rocks do that immediately.

Moving on to Slide 20 in December we presented data from the Phase III Matterhorn study of <unk> in patients with anemia of lower risk Myelodysplastic syndromes at the American Society of Hematology annual meeting.

Thane Wedeck: RoxaduceDeck continues to expand its category leadership in brand value share in China, rising to 42% in the most recent three-month period ending in December of 2023. The potential addition of the chemotherapy-induced anemia indication would create a meaningful catalyst for both continued share and volume growth of roxidustat in China. 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.

Speaker Change: Although we missed the primary endpoint of transfusion independence rocks induced that demonstrated a numerical advantage relative to placebo.

Speaker Change: When looking specifically at results in patients with a higher transfusion burden at baseline.

Speaker Change: A statistically significant and clinically meaningful advantage in transfusion independence in patients treated with <unk> <unk>.

Speaker Change: Versus placebo base.

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: I will now hand, it off to John Hunter, our CFO to cover our early stage pipeline John Thank you theme.

Thane Wedeck: Generic players face lead time and execution risk of market adoption after approval, as they need to be admitted into individual 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.

John Hunter: Moving to slide 22, and a snapshot of our early stage oncology pipeline, consisting of one phase II ready ADC program for metastatic castration resistant prostate cancer and two preclinical immuno oncology programs for today's call I will be focusing on FTE $32 46, <unk> 46.

John Hunter: Erected antibody drug conjugate in development and development for metastatic prostate cancer and potentially other solid tumors.

Thane Wedeck: Despite the expiration of our composition of matter patents in June 2024, we do not expect meaningful deterioration of the rocks of business in the near term. In addition to the continued outstanding performance of RoxaDustat in China, the RoxaDustat launch in Europe is accelerated, showing robust quarter-over-quarter growth. We expect this growth to continue to accelerate, given the fact that RoxyZusta 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, ROCS-DUSTAT maintains its strong competitive position in the EU.

John Hunter: To briefly address our immuno oncology programs.

John Hunter: We anticipate an IND filing per FTE, 31, 65, or <unk> targeted antibody that prevents <unk> mediated immune suppression later this quarter.

John Hunter: We are currently performing IND, enabling activities for FTE $31 75, our anti <unk> antibody for depletion of tumor infiltrating T regulatory cells and expect to file an IND in 2025.

John Hunter: On slide 23 is an overview of FTE 30 to 46.

John Hunter: Ft $32 46, as a potential first in class ADC for metastatic castration resistant prostate cancer colorectal cancer and other tumor types.

Thane Wedeck: Of note, we have recently been successful in defending Roxaducat's patent portfolio and now believe we have exclusivity into 2036, positioning Roxadustat to continue its growth and market leadership over the next decade plus in the EU. Moving to slide 18, today we announced that AstraZeneca returned all U.S. ROW-Roxasustat rights to FibroGen, with the exception of South Korea and China. The collaboration agreement with AstraZeneca for Roxas Dustat in China remains in place, regaining the rights to Roxas Eustat in the U.S. ROW territory allows us to pursue Roxas-Dustet development opportunities On slide 19, we highlight the potential opportunity for roxidustat in patients with anemia associated with 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 look forward to initiating partnership discussions for Roxadustat immediately. Moving on to slide 20.

John Hunter: Ft 30 to 46 binds to a cell receptor target that internalizes upon antibody binding and is present at high levels in prostate cancer and other tumor types, but the demonstrates very limited expression in most normal tissues, making it an ideal ADC target candidate.

John Hunter: Moving to slide 24 ft $32 46 is comprised of an anti CD 46 antibody y S. Five linked to the anti mitotic agent MMA, which is a clinically and commercially validated ADC payload.

John Hunter: FTE $32 46 has demonstrated efficacy against CD 46, expressing tumors in both preclinical and clinical studies.

John Hunter: And associated pet imaging biomarker at 46 utilizes the same targeting antibody as FTE $32 46, and is under clinical development at UCSF. It is comprised of the <unk> five antibody coupled to the radionuclide zirconium 89 and in preclinical studies.

John Hunter: Straight specific targeting of an uptake by CD 46 positive tumors.

John Hunter: We plan to explore its potential use for identifying FTE $32 46 responsive patients in a phase II trial that I will touch upon shortly.

John Hunter: Moving to slide 25.

Thane Wedeck: In December, we presented data from the Phase III Matterhorn study of roxidustat in patients with anemia of lower risk mild dysplastic syndromes at the American Society of Hematology annual meeting, although we missed the primary endpoint of transfusion independence. Roxodustat demonstrated a numerical advantage relative to placebo, and 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 Roxidustat represents an important potential therapy for patients in the U.S. and other territories where it has not yet been approved. I will now hand it off to John Hunter, our CSO, to discuss our early stage pipeline. John?

John Hunter: As we have stated in previous earnings calls FTE $32 46 has demonstrated monotherapy clinical efficacy in multiple myeloma in metastatic castration resistant prostate cancer.

John Hunter: Interim data presented at <unk> 2022 from the Phase one trial in prostate cancer showed that four out of 21 Evaluable patients had partial responses based on resist criteria at the two highest study doses.

John Hunter: It also showed a PSA 50 response rate of 45% in heavily pretreated patients who had a median of five prior therapies.

John Hunter: The safety profile for <unk> hundred $32 46, with consistent with other MMA based ADC therapeutics with neutropenia being the most common adverse event.

John Hunter: Additional data from this recently completed phase one trial will be reported later this quarter.

On slide 26, we show ongoing and planned clinical trials for FTE $32 46.

John Hunter: In addition to the phase one dose escalation and expansion study referenced on the previous slide. There is also a combination study with <unk> that is currently being run at UCSF. The.

John Hunter: Thank you, Thane. Moving to slide 22, a snapshot of our early stage oncology pipeline consisting of one phase two ready ADC program for metastatic castration resistant prostate cancer and two preclinical immuno-oncology programs. For today's call, I will be focusing on FG3246, a CD46-directed antibody drug conjugate in development for metastatic prostate cancer and potentially other solid tumors, to briefly address our immuno-oncology program. We anticipate an IND filing for FG3165, our galactin-9 targeted antibody that prevents gal-9 mediated immune suppression later this quarter. We are currently performing IND enabling activities for FG3175, our anti-CCR8 antibody for depletion of tumor infiltrating T-regulatory cells, and expect to file an IND in 2025. Slide 23 is an overview of FG3246. FT-3246 is a potential 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 at high levels in prostate cancer and other tumor types, but that demonstrates very limited expression in most normal tissues, making it an ideal ADC target candidate.

John Hunter: The rationale for this combination is based on preclinical data demonstrating upregulation of CD 46 in tumor cells. Following <unk> treatment, therefore, potentially making them more responsive to treatment with FG $32 46.

John Hunter: Interim data from this trial is expected in mid 2024.

John Hunter: A trial for the 46 biomarker in prostate cancer is in progress at UCSF. The goal is to develop the screening assay to select patients with high <unk> 46 expression, who are most likely to benefit from treatment with FG $32 46.

John Hunter: The biomarker will be part of the phase III study run by fiber Gen in which approximately 100 patients will be enrolled following a pet scan with pet 46.

John Hunter: Patients will not be stratified at the start of the study, but the correlation between pet positivity and FTE 30 to 46 efficacy will be assessed at the end of the study with the potential to use the pet 46 biomarker to stratify patients in a pivotal phase III trial.

John Hunter: We anticipate the initiation of the phase II trial in metastatic castration resistant prostate cancer in the second half of 2024.

Speaker Change: I will now turn the call over to one gram to discuss the company's financials one.

One Gram: Thank you John.

One Gram: Providing our financial update I would like to remind everyone that full financial results are in our press release and our recently filed 10-K.

One Gram: I will begin my remarks, with our revenue summary for both full year 2023, and fourth quarter of 2023 subsequently providing financial performance detail in our China business for 2023, along with 2024 guidance for China operations. Finally, I will wrap up with operating expense results in our <unk>.

John Hunter: Moving to slide 24, FT3246 is comprised of an anti-CD46 antibody, YS5, linked to the antimyotic agent, MMAE, which is a clinically and commercially validated ADC payload. FG3246 has demonstrated efficacy against CD46-expressing tumors in both preclinical and clinical studies, and an associated PET imaging biomarker, PET46, utilizes the same targeting antibody as FG3246 and It is comprised of the YS5 antibody coupled to the radionuclide zirconium-89, and in preclinical studies, it demonstrates specific targeting of and uptake by CD46 positive tumors. We plan to explore its potential use for identifying FG3246 responsive patients in a phase two trial that I will touch upon shortly. Moving to slide 25.

One Gram: Cash outflows.

One Gram: For the full year 2023, total revenue was 147 $8 million compared to $147 million for the same period in 2022, an increase of 5% year over year. These.

One Gram: These figures highlight the sustainability of the revenues from our Rockford <unk> franchise.

One Gram: We have transitioned from higher development and license revenue in 2022 to higher commercial revenue in 2023.

One Gram: For the fourth quarter of 2023 total revenue was $27 1 million compared to $34 4 million for the same period in 2022.

One Gram: The fourth quarter is $7 $3 million a year over year revenue reduction was primarily driven by shipment timing of drug product revenue to astellas of $5 4 million.

One Gram: Reduction of development revenue from our <unk> partners of $1 9 million.

One Gram: And from changes in the assumptions of our China single performance obligation model, which adjusts prior and future revenue for changes in many variables.

One Gram: Such as forecasted future volumes sold.

One Gram: Forecasted future price in forecasted foreign exchange amongst other assumptions.

John Hunter: As we have stated in previous earnings calls, FG3246 has demonstrated monotherapy clinical efficacy in multiple myeloma and metastatic castration-resistant prostate cancer. Interim data presented at ASCO 2022 from the phase one trial in prostate cancer showed that 4 out of 21 valuable patients had partial responses based on resistance criteria at the two highest study doses. It also showed a PSA-50 response rate of 45% in heavily pretreated patients who had a median of five prior therapies. The safety profile for FG3246 was consistent with other MMAE-based ADC therapeutics, with neutropenia being the most common adverse event.

One Gram: Diving deeper on the financial performance of our business in China.

One Gram: 23 full year net sales of <unk> by fiber, Jim and the joint distribution entity or J D. E owned by Astrazeneca and fiber, Jim was $284 1 million compared to $208 8 million in 2022.

One Gram: Significantly healthy grow growth of 36% year over year.

One Gram: In Q4, 2023 fiber M. J D E. Net sales were $66 5 million compared to $53 $1 million in the fourth quarter of 2022.

One Gram: An increase of 25, 2% year over year.

One Gram: Q4 revenue reflects distributor inventory adjustment due to the renewed NR deal price representing.

One Gram: An impact of $5 $3 million or a 10% impact from growth year over year.

John Hunter: Additional data from this recently completed Phase 1 trial will be reported later this quarter. On slide 26, we show ongoing and planned clinical trials for FG3246. In addition to the phase one dose escalation and expansion study referenced on the previous slide, there is also a combination study 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 following enzalutamide treatment, therefore potentially making them more responsive to treatment with FG3246. Interim data from this trial is expected in mid-2024. A trial for the PET-46 biomarker in prostate cancer is in progress at UCSF.

One Gram: As a reminder, our recent inclusion into the 2023 and our deal came with a 7% price reduction.

One Gram: The sales performance of <unk> in China Substantiates, the achievement of the highest value share since launch at 42% of the category in Q4 2023.

One Gram: From total <unk> net sales in China.

One Gram: <unk> Jensen that transfer price from sales to the J D E was $88 $6 million and $21 3 million for the full year of 2023 in Q4 2023, respectively.

One Gram: This compared to 68, 8% and $17 2 million for the full year and fourth quarter of 2022, respectively.

One Gram: An increase of 28, 8% and full year 2023, and 23 eight in the fourth quarter of 2023.

One Gram: As a reminder, net transfer price is the best approximation of fiber portion of the cash in our train operations.

John Hunter: The goal is to develop a screening assay to select patients with high CD46 expression who are most likely to benefit from treatment with FG3246. The biomarker will be part of a Phase 2 study run by FibroGen in which approximately 100 patients will be enrolled following a PET scan with PET46. Patients will not be stratified at the start of the study, but the correlation between PET positivity and FG32-46 efficacy will be assessed at the end of the study with the potential to use the PET-46 biomarker to stratify patients in a pivotal phase three trial. We anticipate the initiation of the phase 2 trial in metastatic castration-resistant prostate cancer in the second half of 2024. I will now turn the call over to Juan Graham to discuss the company's financials. Okay, Juan?

One Gram: As a result for full year 2023 fiber Gen recorded $89 million in net revenue from <unk> sales to the JV and $11 $9 million up direct to distributor sales from fibers in China totaling $100 9 million on a U S GAAP basis.

One Gram: For Q4, 2023 fiber Gen revenue from rest of the <unk> sales through the JV was $20 7 million and $2 $8 million of direct to distributor sales from fiber to in China totaling $23 $5 million in the U S GAAP basis.

One Gram: Our revenue growth highlights the continuous robustness and commercial execution and sufficient and patient adoption of <unk> in China.

One Gram: For full year 2024, we are forecasting fiber Gen trained up product revenue to be in the 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: Thank you, John. Before providing our financial update, I would like to remind everyone that the full financial results are in a press release and the recently filed 10-K. I will begin my remarks with a revenue summary for both full year 2023 and fourth quarter of 2023, subsequently providing financial performance detail on our China business for 2023, along with 2024 guidance for our China operation. Finally, I will wrap up with operating expense results and our cash out. For the full year 2023, total revenue was $147.8 million compared to $140.7 million for the same period in 2022, an increase of 5% year over year. These figures highlight the sustainability of the revenues from our ROC-FDUSTEC franchise as we have transitioned from higher development and licensed revenue in 2022 to higher commercial revenue in 2023. For the fourth quarter of 2023, total revenue was $27.1 million compared to $34.4 million for the same period in 2022. The fourth quarter's $7.3 million year-over-year revenue reduction was primarily driven by shipment timing of drug product revenue to a status of $5.4 million.

Now moving down the income statement, our operating costs and expenses for the fourth quarter of 2023 were $81 3 million compared to $100 5 million for the fourth quarter of 2022.

One Gram: A decrease of $19 $2 million year over year, reflecting a reduction in expenses as previously communicated through clinical trials shutdowns SG&A efficiencies in the U S headcount reductions at.

One Gram: Approximately 65% or 51 7 million so for operating expenses Watson R&D expenses.

One Gram: Of this approximately 59% was related to prime revenue, 32% allocated to support of our early stage pipeline and the remaining 9% directed towards development activities in the United States and China.

One Gram: During the fourth quarter of 2023, we recorded a net loss of $56 2 million or <unk> 57, net loss for both basic and diluted share.

As compared to a net loss of $66 2 million or <unk> 17 per basic and diluted share for the fourth quarter of 2022.

One Gram: On slide 28, we highlight our performance against our prior savings guidance.

One Gram: I am pleased to announce that we have successfully achieved our cost reduction plan of approximately $120 million in total annualized expenses were approximately $30 million per quarter, one quarter earlier than expected.

Juan Graham: Reduction of development revenue from our RockSeduceTec partners of $1.9 million, and from changes in the assumptions of our China Single Performance Obligation Model, which adjusts prior and future revenue for changes in many variables, such as forecasted future volume sold, forecasted future price, and forecasted foreign exchange amongst other assumptions, diving deeper into the financial performance of our business in China. 2023 full-year net sales of RoxaDusta by FibroGen and the Joint Distribution Entity (JDE) owned by AstraZeneca and FibroGen were $284.1 million compared to $208.8 million in 2022, a significantly healthy growth of 36% year-over-year. In Q4 2023, FibroGen and JDE net sales were $66.5 million compared to $53.1 million in the fourth quarter of 2022, an increase of 25.2% year-over-year. Q4 revenue reflects distributor inventory adjustments due to the renewed NRDL price, representing an impact of $5.3 million or a 10% impact on growth year-over-year.

One Gram: We now forecast, our total operating expenses, including Cogs.

One Gram: To be between $70 million to $80 million per quarter for the first half of 2024.

One Gram: 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.

One Gram: Now shifting towards cash as of December 31, we reported $248 $1 million in cash cash equivalents investments and accounts receivable.

One Gram: As we move forward, we expect our quarterly cash burn rate to reflect the reduction in operating expenses that we have been able to successfully achieve.

One Gram: 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 plan into 2026.

One Gram: <unk>.

One Gram: And that would like to turn the call back over to Wayne.

Wayne: Thanks, Juan 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 <unk> pivotal studies.

A phase III pancreatic cancer action network precision promise trial in metastatic pancreatic cancer in the second quarter of 2024, and the phase III <unk> trial in locally advanced pancreatic cancer also in the second quarter of 2024.

Juan Graham: As a reminder, a recent inclusion in the 2023 NRDL list came with a 7% price reduction. The sales performance of Roxodusta in China substantiates the achievement of the highest value share since launch at 42% of the category in Q4 2023. From total ROXADUCE.NET sales in China, FibroGen's net transfer price from sales to the JDE was $88.6 million and $21.3 million for the full year of 2023 and Q4 2023, respectively.

Wayne: <unk> continues to perform very well in China, where our <unk> NDA has been accepted for the chemotherapy induced anemia indication and our partner Astellas continues with the commercialization of <unk> in Europe, Japan and other markets. Additionally.

Wayne: Additionally, we are excited to regain the rights for <unk> for U S. <unk> territories from Astrazeneca, and we will be exploring potential partnering opportunities in Mds.

Wayne: With our early stage pipeline, we expect additional data from the phase one monotherapy study of FG $32 46 in metastatic castration resistant prostate cancer. Later this quarter, we anticipate the initiation of a phase II trial NMC RPC in the second half of 2024, we.

Juan Graham: This compared to $68.8 and $17.2 million for the full year and fourth quarter of 2022, respectively, an increase of 28.8% in the full year 2023 and 23.8% in the fourth quarter of 2023. As a reminder, the net transfer price is the best approximation of FibroGen's portion of the cash in our China operation. As a result, for a full year 2023, FibroGen recorded $89 million in net revenue from Roxa-Dustat sales to the JDE and $11.9 million of direct-to-distributor sales from FibroGen China, totaling $100.9 million on a U.S. GAAP basis. For Q4 2023, FibroGen revenue from Ruxidustat sales to the JDE was $20.7 million, and $2.8 million of direct-to-distributor sales from FibroGen China, totaling $23.5 million in the U.S. gap base.

Wayne: We anticipate filing an IND.

Wayne: For FG $31 65, our anti <unk> antibody in the first quarter of 2024.

Wayne: And we anticipate filing an IND for <unk> 31, 75, our anti <unk> antibody in 2025.

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

Wayne: 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 <unk> revenue stream.

Wayne: Near term <unk> readouts in pancreatic cancer.

Wayne: Our oncology pipeline and our strong balance sheet.

I would like to thank all the employees of fiber and for their continued hard work and perseverance over the last few months.

Speaker Change: I would now like to turn the call over to the operator for Q&A.

Speaker Change: Thank you.

Speaker Change: Ladies and gentlemen, if you'd like to ask a question. Please press star one on your Touchtone telephone again to ask a question. Please press star 111 moment for our first question.

Operator: Our first question comes from the line of Andy Hossain of William Blair. Your line is open.

Juan Graham: Our revenue growth highlights the continuous robustness in commercial execution and physician and patient adoption of ruxidustat in China. For full year 2024, we are forecasting FibroGen China product revenue to be between $120 to $135 million on a US GAAP basis, which assumes an underlying forecast of ROXADUSTAT net sales in China to range from $300 to $340 million. Now moving down the income statement, our operating costs and expenses for the fourth quarter of 2023 were $81.3 million compared to $100.5 million for the fourth quarter of 2022, a decrease of $19.2 million year-over-year, reflecting our reduction in expenses as previously communicated through clinical trial shutdowns, SG&A efficiencies, and U.S. headcount reductions. Approximately 65% or $51.7 million of our operating expenses were for R&D expenses.

Andy Hsieh: Oh, great. Thanks for taking my questions.

Andy Hossain: Yes.

Andy Hsieh: <unk> development with the <unk> right.

Andy Hsieh: Regaining rocket is that right.

Andy Hsieh: So.

Starting with <unk> looking at your guidance of 12% growth based on the J D E revenues.

Andy Hsieh: Combined with the price reductions so can we kind of extrapolate it.

Andy Hsieh: Anticipating roughly about a 20% volume growth this year.

Andy Hsieh: And moving on to <unk>.

Andy Hsieh: The CD 46 ADC.

Andy Hsieh: Look forward to the cable I'll call that Youre scheduling.

Andy Hsieh: The waterfall plot that was presented at.

Andy Hsieh: Ask a 2020 to theirs.

Andy Hsieh: Pretty clear dose response.

Andy Hsieh: I'm curious about the phase III program.

Andy Hsieh: Which dose you are thinking about starting I think in the presentation. It says something about the one two milligram per kilogram.

Andy Hsieh: As the millet minimally efficacious dose.

Andy Hsieh: But I guess the dosage size really was demonstrated at the $2. Four just curious just curious about the dosing scheme that youre thinking about and one thing about the phase III.

Juan Graham: Of this, approximately 59% was related to Pemreblumab, 32% allocated to support our early stage pipeline, and the remaining 9% directed towards Ruxedusta development activities in the United States and China. During the fourth quarter of 2023, we recorded a net loss of $56.2 million, or $0.57 net loss per basic and diluted share, as compared to a net loss of $66.2 million, or $0.70 per basic and diluted share for the fourth quarter of 2022. On slide 28, we highlight our performance against our prior savings guidance. I am pleased to announce that we have successfully achieved our cost reduction plan of approximately $120 million in total annualized expenses, or approximately $30 million per quarter, one quarter earlier than expected. We now forecast our total operating expenses, including COGS, to be between 70 to 80 million dollars per quarter for the first half 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 pembrokelimab and pancreatic cancer. Now shifting towards cash, as of December 31st, we reported $248.1 million in cash, cash equivalents, investments, and accounts receivable.

Andy Hsieh: Design are you thinking about the prophylactic G CSF administration for patients.

Speaker Change: Hey, Andy Thanks, So much for your question regarding rocks are volume growth in China. I think if you were to look at kind of the midpoint of the $300 million to $340 million guidance that you'd be right in that ballpark from a volume growth perspective.

Speaker Change: We will we will be able to provide more guidance when we have clarity on the CIA indication and the approval of that indication as well.

Speaker Change: But I think that your math works out pretty well.

Speaker Change: As it relates to the phase two.

Speaker Change: Design <unk>.

Speaker Change: Regarding dose in prophylactic G CSF I'll, let John handle that question.

John Hunter: Thanks, Hi, Andy how are you.

John Hunter: Yes, just with regards to your question. So the one two Meg per kg in the phase one trial with.

John Hunter: The dose where they saw biologic activity.

John Hunter: As evidenced by the PSA 50 responses.

John Hunter: And they did see PSA 50 responses and stable disease escalating up to those higher doses.

John Hunter: $2 7 million three mix per kg.

John Hunter: With regards to the phase two dose.

John Hunter: I do want to dose what we think the highest tolerable doses. So we're really going to try to balance the efficacy that we saw in the phase one trial, along with some of the adverse event profiles that we're seeing in our analysis of the data.

John Hunter: We will share that information.

John Hunter: <unk> about the time.

John Hunter: We are presenting the results from the phase one trial.

Juan Graham: As we move forward, we expect our quarterly cash burn rate to reflect the reduction in operating expenses that we have been able to successfully achieve. 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. Thank you. And now I would like to turn the call back over to, Juan.

Speaker Change: Got it.

Speaker Change: If you don't mind, let me squeeze in one more for Penn verbal Matt So for the precision promise study.

Speaker Change: How does the top line results logistics will work out. So do you have to go back to Pat can kind of formulate some sort of disclosure strategy or it's up to you or it's up to them to talk about that.

Speaker Change: Just informed investors what to expect thank you.

Thane Wedeck: 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 Pemrevel MAP pivotal studies. The Phase 2-3 Pancreatic Cancer Action Network Precision Promise Trial in Metastatic Pancreatic Cancer in the second quarter of 2024 and the Phase 3 LAPIS Trial in Locally Advanced Pancreatic Cancer also in the second quarter of 2024. Roxazustat continues to perform very well in China, where our SNDA has been accepted for the chemotherapy-induced anemia indication, and our partner Astellas continues with the commercialization of Roxazustat in Europe, Additionally, we are excited to regain the rights to RoxyDustat in U.S. ROW territories from AstraZeneca, and we'll be exploring potential partnering opportunities in MDS.

Speaker Change: Yes, good question, Andy and after I answer that question I'll turn it back over to John to address the G. CSF piece of your of your previous question as well.

Speaker Change: And so.

Speaker Change: Because it is a pan can sponsored study.

Speaker Change: Pan can we will.

Speaker Change: Association with Woodbury and associates, which is the world leader in Bayesian Statistical design and analysis. They will do the analysis of the primary OS endpoint and then communicate that to us.

John Hunter: And so again because they are the sponsor of the study.

John Hunter: They are accountable for the statistical analysis plan that will be working in close collaboration with them and we're still working through some of the details as it relates to how the top line primary OS result will be communicated.

John Hunter: Because it is a pan cancer sponsored study they're responsible for that.

John Hunter: And Andy just to address your question about the prophylactic G CSF.

Thane Wedeck: With our early stage pipeline, we expect additional data from the phase one monotherapy study of FG3246 in metastatic castration-resistant prostate cancer later this quarter. We anticipate the initiation of a phase two trial in MCRPC in the second half of 2024. We anticipate filing an IND for FG3165, our anti-Gal-9 antibody, in the first quarter of 2024, 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.

John Hunter: We are looking at having prophylactic G CSF as part of the Phase III study design. This was incorporated into the investigators sponsored combination trial that is currently running at UCSF and so we're looking at the results from that trial as we plan out our phase two and start thinking of.

John Hunter: Having G CSF to prevent neutropenia and our patients.

Got it.

Speaker Change: That's super helpful. Thank you so much.

Speaker Change: Thanks, Andy.

Speaker Change: Thank you one moment please.

Speaker Change: Our next question comes from a lot of Paul Choi of Goldman Sachs. Your line is open.

Paul Choi: Hi, good afternoon team and thanks for taking our questions.

Paul Choi: I have two on $32 46, and I guess with the phase one monotherapy results eminent here I guess how.

Paul Choi: How would you direct investors on the street, just sort of think about interpreting the results would you just focus.

Thane Wedeck: 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 Roxas-Dustat revenue stream, near-term PAM-Revlimab readouts in pancreatic cancer, our oncology pipeline, and our strong balance sheet. I would like to thank all the employees of FibroGen for their continued hard work and perseverance over the last few months. I would now like to turn the call over to the operator for Q&A.

Paul Choi: You seem to be emphasizing just on the highest dose doses as potentially the most therapeutics.

Paul Choi: Relevant here.

It's a focus also on demonstrating a broader dose response, and then I had a follow up question on the on the combination study.

Paul Choi: Thanks.

Speaker Change: Paul John you want to if I can take.

Speaker Change: Yeah. Thanks for the question Paul.

Paul: And looking at the broader dataset that was presented at <unk> and also what we plan on rolling out with the completed phase one trial.

Operator: Thank you. Again, ladies and gentlemen, if you'd like to ask a question, please press star 1-1 on your touch-tone telephone. Again, to ask a question, please press star 1-1 on your touch-tone telephone. Star 1, One moment for our first. Our first question comes from the line of Andy Hsieh of William Blary Lines.

Paul: The objective responses were all seen at the highest doses, but the PSA 50 responses, which are also considered very important in this in this disease.

Paul: We're seeing down to 1.2 mix per gig.

Andy Hsieh: Oh, great. Thanks for taking my questions. You know, a very intriguing development with the Roxaducat rights, or regaining Roxaducat rights.

Paul: And then looking at the progression free survival data, which we'll be sharing later this quarter.

Paul: We have seen that there were some durable responses even at some of the lower doses. So I wouldn't focus entirely on the highest doses I would look at the broader dataset.

Thane Wedeck: So starting with Roxaducat, looking at your guidance of 12% growth based on JDE revenue, combined with a price reduction, can we extrapolate that you're anticipating roughly about a 20% volume growth this year? And moving on to the CD4680C, look forward to the KOL call that you're scheduling. In the waterfall plot that was presented at ASCO 2022, there's a pretty clear dose response. I'm curious about the phase two program, at which dose you're thinking about starting. I think in the presentation it says something about 1.2 milligram per kilogram as the minimally efficacious dose, but I guess the dose response really was demonstrated at 2.4. Just curious about the dosing scheme that you're thinking about. And one thing about the phase two design: are you thinking about prophylactic DCSF administration for patients?

Paul: Obviously, we're going to need to settle on a phase II dose that we move forward with that as I had mentioned in my previous answers. We are taking safety into account together with the efficacy that was seen.

Paul: And then Paul maybe one other comment to tag on to what John said, recognizing that the phase one cohort was a heavily pre treated patient population with a median of five lines of therapy prior to receiving FG $32 46.

Paul: There are some things you can interpret relative to the phase one data in <unk> and perhaps some things that.

Paul: We'll have to wait until we see the phase II results, because we're going to be studying this in a different patient population, we're not going to be waiting for patients who have been pretreated with that many courses of therapy prior to exposing them to <unk> $32 46.

Thane Wedeck: Hey, Andy, thanks much for your question. Regarding rocks of volume growth in China, you know, I think if you were to look at kind of the midpoint of, you know, the 300 to $340 million guidance, you'd be right in that ballpark from a volume growth perspective. We did, we will, we'll be able to provide more guidance when we have clarity on the CIA indication and the approval of that indication as well. But I think that your math works out pretty well.

Speaker Change: Great. Thanks for that and then as a follow up you referenced the UCF sponsored study in combination with Andy here.

Speaker Change: Recognizing that the study is investigator driven and not in your control.

Speaker Change: But it is in an earlier population. So I guess as you think about the pending results from the monotherapy study versus potentially going in earlier lines with a combination program with sandy and our other agents.

Speaker Change: How would you rank order prioritizing those developments.

Speaker Change: Terms of advancing to phase II studies would you want to wait till you see the see that combination results out of out of UCSF. Thank you so much for taking our questions.

John Hunter: As it relates to the phase two design, regarding dose and prophylactic GCSF, I'll let John handle that question. Thanks, Zane. Hi Andy, how are you?

Speaker Change: Yeah. Thanks, Paul Great question, we do want to see at least some of the data out of UCSF before we would prioritize that relative to the monotherapy trial.

John Hunter: Yeah, just with regard to your question. So the 1.2 mg per kg in the phase one trial was the dose where they saw biological activity, you know, as evidenced by the PSA-50 responses. And they did see PSA-50 responses in stable disease, escalating up to those higher doses of 2.7 and 3 mg per kg. With regard to the phase two dose, we do want to dose what we think are the highest tolerable doses.

Speaker Change: Lee if we do see really decided clinical benefit with the combination.

Speaker Change: That would be a pretty high priority for us moving forward and planning our clinical trials.

Lee: And then knowing that there is just tremendous opportunity across the entire spectrum patients with prostate cancer. So I hope we have to make those trade off decisions Paul.

John Hunter: So we're really going to try to balance the efficacy that we saw in the phase one trial, along with some of the adverse event profiles that we're seeing in our analysis of the data. We will share that information probably about the time that we are presenting the results from the phase one trial. Got it. And if you don't mind, let me squeeze in one more for Pembrebemab.

Lee: [laughter].

Lee: Yeah.

Speaker Change: Great. Thanks, so much.

Speaker Change: Thank you one moment please.

Our next question comes from the line of Jason <unk> of Bank of America. Your line is open.

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

Gino: Thank you so much for taking our question.

Gino: And then just had a couple on F 30 to 46.

Thane Wedeck: So for the Precision Promise study, how will the top line results logistically work out? So do you have to go back to the pan and can and kind of formulate some sort of disclosure strategy, or is it up to you or it's up to them? So just going to talk about that, just to inform investors what to expect. Thank you. Yeah, good question, Andy.

Gino: So on the phase one top line data could you just frame the scope of the update.

Gino: Terms of patient number and duration of follow up.

Speaker Change: Do you get.

Speaker Change: Two to four responses in the dose expansion cohort so as you can.

Speaker Change: It is a favorable advancement.

Speaker Change: Given how heavily pretreated patients are and I just have one follow up to that.

Speaker Change: Yes. Thanks for the question just with regards to the scope of the data that will be.

Thane Wedeck: And after I answer that question, I'll turn it back over to John to address the GCSF piece of your previous question as well. And so, you know, because it is a PanCan-sponsored study, PanCan, in association with Barry and Associates, which is, you know, the world leader in Bayesian statistical design and analysis, they will do the analysis of the primary OS endpoint and then communicate that to us. And so, again, because they are the sponsor of the study, they're accountable for the statistical analysis plan. Now, we'll be working in close collaboration with them, and we're still working through some of the details as it relates to how the top-line primary OS result will be communicated. But because it is a PanCan-sponsored study, they're responsible for that.

Speaker Change: Talking about when we released the results.

Speaker Change: We're going to focus pretty much on the same readouts.

Speaker Change: Were shown at <unk>.

Speaker Change: <unk> 2022.

Speaker Change: With the objective responses in the PSA 50 responses.

Speaker Change: But really a pretty standard way of looking at data currently in metastatic castration resistant prostate cancer is the composite response rate that includes.

Speaker Change: Either the PSA 50 responses and or the objective responses.

Speaker Change: One thing that we will have more mature data on will be progression free survival.

Speaker Change: A lot of the patients who are on study at the time of Vasco obviously of the <unk>.

Speaker Change: Extend it out in terms of their treatment cycles. So we will have that data as well in terms of what we will see as being favorable.

Thane Wedeck: And Andy, just to address your question about prophylactic GCSF, we are looking at having prophylactic GCSF as part of the phase two study design. This has been incorporated into the investigator-sponsored combination trial that's currently running at UCSF. And so we're looking at the results from that trial as we plan out our phase two and start thinking about having GCSF to prevent neutropenia in our patients. That's super helpful.

Speaker Change: As <unk> mentioned this is a very heavily pretreated group.

Speaker Change: A group of patients.

Speaker Change: So it's hard to do direct comparisons against other drug trials, because the patient populations vary.

Speaker Change: But given.

Speaker Change: The data that was presented at <unk>, we view that as very favorable and I think an extension of those results to the end of the phase one trial. We would view is in fact very favorable.

John Hunter: Thank you so much. Thanks, Andy. Thank you. One moment, please. Our next question comes from the line of Paul Choi of Goldman Sachs. Your line is open.

Speaker Change: Got it thank you and just curious.

Speaker Change: There is a reason.

Paul Choi: Hi, good afternoon team, and thanks for taking our questions. I have two on 3246, and I guess with the phase one monotherapy results imminent here, how would you direct investors in the industry to think about interpreting the results? Would you just focus, as you seem to be emphasizing, just on the highest doses as potentially the most therapeutically relevant here, or is the focus also on demonstrating a broader dose response? And then I had a follow-up question about the combination study. Thanks, Paul.

Data cut of the seaborne data there wasn't.

Speaker Change: A correlation between PSA 50 response rate and CD 46 expression.

Speaker Change: Im curious if you have any explanation for that and also maybe how we should be thinking about how that data fits into the context.

Speaker Change: Identifying identifying patients with <unk> expression.

Speaker Change: Part of your development plan.

Speaker Change: Yes, no thats a very good point the IH CE assay that was used to assess CD 46 expression in those patients.

Speaker Change: May not be representative of what we would have seen had we been able to do the IH C with the targeted antibody itself.

Thane Wedeck: John, you want to go ahead and take... Yeah, thanks for the question, Paul. So, in looking at the broader data set that was presented at ASCO and also what we plan on rolling out with the completed Phase 1 trial, the objective responses were all seen at the highest doses, but the PSA-50 responses, which are also considered very important in this disease, were seen down to 1.2 mg per kg. And in looking at the progression-free survival data, which we'll be sharing later this quarter, we have seen that there were some durable responses, even at some of the lower doses. So, I wouldn't focus entirely on the highest doses; I would look at the broader data set.

Speaker Change: Because there are some differences that have been noted NIH C with wyeth five targeting antibody.

Speaker Change: And some of the commercially available reagents that work better on formula and fixed tissue. One of the reasons. We're very excited about the pet biomarker is that we do use the same antibody. It sees the same epitope and we think that that will be a much more reliable indicator of how expression correlates with efficacy.

Got it thank you so much.

Speaker Change: Thank you I'm showing no further questions at this time I'd like to turn the call back over to CEO of <unk> for any closing remarks.

Speaker Change: Yes. Thanks, everyone. We appreciate your participation in today's call and your continued interest in <unk>.

John Hunter: Obviously, we're going to need to settle on a phase two dose that we move forward with, but as I had mentioned in my previous answers, we are taking safety into account, together with the efficacy that was seen. Yeah, and Paul, maybe one other comment to add to what John said.

Speaker Change: And we'd love for you guys to enjoy the rest of your day. Thank you.

Speaker Change: Thank you ladies and gentlemen, this does conclude today's conference. Thank you all for participating you may now disconnect have a great day.

Thane Wedeck: You're recognizing that the phase one cohort was a heavily pretreated patient population with a median of five lines of therapy prior to receiving FG32-46. I think there are some things you can interpret relative to the phase one data and perhaps some things that we'll have to wait until we see the phase two results because we're going to be studying this in a different patient population. We're not going to be waiting for patients who have been pre-treated with that many courses of therapy prior to exposing them to FG3246.

Speaker Change: [music].

John Hunter: Thanks for that. And then, as a follow-up, you referenced the UCF-sponsored study in combination with Xtandi here, recognizing that study is investigator-driven and not totally in your control, but it is an earlier population. So I guess, as you think about the pending results from the monotherapy study versus potentially going in earlier lines with a combination program with Xtandi and or other agents, how is your rank order prioritizing those developments in terms of advancing to Phase II studies? Would you want to wait until you see the combination results out of UCSF? Thank you so much for taking our questions. Yeah, thanks, Paul. Great question!

Paul Choi: We do want to see at least some of the data from UCSF before we would prioritize that relative to the monotherapy trial. Obviously, if we do see a really, you know, decided clinical benefit with the combination, that would be a pretty high priority for us moving forward in planning our clinical trials and knowing that there's just tremendous opportunity across the entire spectrum of patients with prostate cancer. So I hope we have to make those trade-off decisions, Paul.

Thane Wedeck: Great. Thanks so much. Thank you. One moment, please.

Operator: Our next question comes from the line of Jason Gerberi of Bank of America. Your line is open. Hi, good afternoon. This is Dina for Jason.

Dina: Thank you so much for taking our questions. We just had a couple on FG 3246. So on the phase one top-line data, could you just frame the scope of the update in terms of patient number and duration of follow-up, and if you get, say, you know, two to four responses in this dose expansion cohort, would you consider this a favorable advancement given how heavily pretreated the patients are? And I just have one follow-up. Yeah, thanks for the question.

John Hunter: Just with regard to the scope of the data that we'll be, you know, talking about when we release the results. We're going to focus pretty much on the same readouts that were shown at ASCO 2022 with the objective responses and the PSA-50 responses. But really, a pretty standard way of looking at data currently in metastatic castration-resistant prostate cancer is the composite response rate that includes either the PSA-50 responses or the objective responses.

John Hunter: One thing that we will have more mature data on will be progression-free survival. A lot of the patients who are on study at the time of ASCO obviously have extended out in terms of their treatment cycle, so we will have that data as well.

John Hunter: In terms of what we'll see as being favorable, as Thayne mentioned, this is a very heavily pre-treated group of patients. And it's hard to do direct comparisons against other drug trials because the patient populations vary. But given the data that was presented at ASCO, we viewed that as very favorable, and I think an extension of those results to the end of the phase one trial would be, in fact, very favorable. I got it.

Dina: Thank you. And just curious if there's a reason that, you know, in the initial data cut of the SAVE-1 data, there wasn't a correlation between PSA-50 response rate and CD46 expression. I'm curious if you have an explanation for that and also maybe how we should be thinking about how that data fits into the context of identifying patients with CD46 expression as a part of your development. Yeah, no, that's a very good point.

John Hunter: The IHC assay that was used to assess CD46 expression in those patients may not be representative of what we would have seen had we been able to do the IHC with the targeted antibody itself because there are some differences that have been noted in IHC with YS5, the targeting antibody, and some of the commercially available reagents that work better on formalin-fixed tissue. One of the reasons we're very excited about the PET biomarker is that we do use the same antibody. It sees the same epitope, and we think that that will be a much more reliable indicator of how expression correlates with efficacy. I got it.

Dina: Thank you so much. Thank you. I'm showing no further questions at this time. I'd like to turn the call back over to CEO Thane Weddick for any closing remarks. Yeah, thanks, everyone. We appreciate your participation in today's call and your continued interest in FibroGen. And we'd love for you guys to enjoy the rest of your day.

Speaker Change: [music].

Operator: Thank you. Thank you. Ladies and gentlemen, this does conclude today's conference. Thank you all. You may now disconnect. Have a great day. ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? GEOFFREY PORGES ANDY HSIEH GEOFFREY PORGES ANDY HSIEH GEOFFREY PORGES [inaudible] ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? Thank you for standing by and welcome to FibroGen's fourth quarter and full year 2023 earnings conference call. At this time, all participants are on a listen-only mode.

Operator: After the speaker's presentations, there will be a question and answer session. To enter a question at that time, please press star 1 1 on your telephone. Please be advised that today's call is being recorded. I would like to call over to your host, Mr. David DeLaChia, Vice President of Investor Relations. Please go ahead. Good afternoon, everyone.

David DeLaChia: Thank you for joining us today to discuss our fourth quarter and year-end 2023 financial and business results. I'm David DeLaChia, Vice President of Corporate FP&A and Investor Relations at FibroGen. Joining me on today's call are Sane Wettick, our Chief Executive 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 DeLaChia: I would like to remind you that remarks made on today's call include forward-looking statements about fibro... Such statements may include, but are not limited to, our collaborations with AstraZeneca and Astellas, financial guidance, the initiation, enrollment, design, conduct, and results of clinical trials, our regulatory strategies and potential regulatory results, our research and development activities, commercial results and results of operations, risks related to our business, and certain other business 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.

David DeLaChia: 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 investor section of FibroGen's website at www.fibrogen.com. With that, I would like to turn the call over to Thane Wedeck, our Chief Executive Officer. Thank you, Dave.

Thane Wedeck: Good afternoon, everyone, and welcome to our fourth quarter and year-end 2023 earnings call. Although 2023 posed numerous challenges for our organization, we are excited about our prospects in 2024, which we believe will be a pivotal year marked by a number of important clinical readouts across our oncology pipeline and continued growth of our Roxidustat franchise. On today's call, I will focus our stakeholders on the four strategic pillars shaping our company's future trajectory.

Thane Wedeck: Additionally, I'll offer insights into the progress of our PemRevelMab and Rox2STAT programs. Dr. John Hunter, our Chief Scientific Officer, will then review our exciting oncology pipeline. Last, Juan Graham, our CFO, will review the financials, after which we will open the call to your questions.

Thane Wedeck: Starting on slide three, FibroGen has four key strategic pillars that we believe offer significant value today versus Pam Revlimab, where we are expecting readouts from two pivotal phase three studies in pancreatic cancer in the coming months. In January, we announced the graduation and completion of the PAMREVELMAB arm in Precision Promise, the Pancreatic Cancer Action Network's Phase 2-3 Adaptive Platform Trial for Metastatic Pancreatic Cancer, where we anticipate top-line data in the second quarter of this year. We are now anticipating top-line data from our ongoing LAPIS Phase 3 trial in locally advanced pancreatic cancer in the second quarter of 2024 as well. Pancreatic cancer is a disease with substantial unmet medical need and represents a significant commercial opportunity for PAM-Revlimab, which has demonstrated effectiveness in both preclinical and early clinical studies, which we will detail in a moment. Second, is Roxadustat.

Speaker Change: [music].

Thane Wedeck: Roxadustat is approved in over 40 countries, generates significant net revenue and positive cash flow, and provides FibroGen with material and growing profits through our partnerships with AstraZeneca and Astellas Pharma. Today, we announce that FibroGen has regained the rights to Roxidustat from our partner AstraZeneca in the U.S. and ROW territories, excluding China and South Korea. This allows us the opportunity to potentially partner Roxidustat in certain indications with high-end met needs, such as anemia and myodysplastic syndromes, which I will touch on later in the call. Third, we have an early-stage oncology pipeline. We are very excited about the potential of these programs.

Thane Wedeck: FG-3246 is a first-in-class potent antibody drug conjugate, or ADC, for the treatment of metastatic castrate-resistant prostate cancer. This program also includes the development of an associated CD46 targeted pet biomarker. We anticipate releasing additional data from our FG3246 Phase 1 monotherapy trial in the coming week. In addition to FG3246, we are also undertaking IND-enabling activities on two innovative oncology antibodies with the intention of filing an IND for FG3165, our anti-collectin 9 monoclonal antibody, in the first quarter of 2024 and FG3175, our anti-CCR8 monoclonal antibody, in 2025. The fourth pillar is our strong cash position. We finished the year with approximately $248.1 million in cash, cash equivalents, and accounts receivable.

Speaker Change: Thank you for standing by and welcome to fiber Jones fourth quarter and full year 2023 earnings conference call.

At this time all participants are in a listen only mode.

Speaker Change: After the Speakers' presentation there'll be a question and answer session to enter a question at that time. Please press star one on your telephone.

Speaker Change: Please be advised that today's call is being recorded.

Speaker Change: I would like to turn the call over to your host Mr. David David Shea.

David Shea: Vice President of Investor Relations. Please go ahead.

David Shea: Good afternoon, everyone. Thank you for joining today to discuss our fourth quarter and year end 2023 financial and business results I'm, David <unk>, Vice President of corporate SG&A and Investor Relations at fiber John joining me on today's call are saying, what our Chief Executive Officer, Juan Graham, Our Chief Financial Officer.

Speaker Change: Dr. John Hunter, our Chief Scientific Officer, and Chris Chung, Our senior Vice President of China operations.

Thane Wedeck: In the fourth quarter, one quarter earlier than expected, we successfully executed on our company-wide cost reduction plan, which provides us with the ability to achieve several key milestones across our portfolio. We have taken the necessary steps to improve our strong financial position and will continue to focus on financial discipline. 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. Moving to slide 5, Pamrevelmeb is a novel anti-CTGF human monoclonal antibody in clinical development for the treatment of metastatic pancreatic cancer and locally advanced unrespectable pancreatic cancer or LAPC.

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 Jeff such.

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.

Speaker Change: Our research and development activities.

Speaker Change: Commercial results and results of operations risks related to our business and certain other business matters. Each forward looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in that statement a more complete description of these and other material risks can be found in fiber dense filings with the SEC.

Speaker Change: T SEC, including our most recent Form 10-K and Form 10-Q five.

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 a 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 five regions website at Www Dot fiber Gen dotcom.

Thane Wedeck: 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 adverse event and safety profile. I would now like to discuss the PAM-Revlimab opportunity in pancreatic cancer in more detail, starting on slide 6. 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: With that I would like to turn the call over to <unk>, Our Chief Executive Officer.

Speaker Change: Thank you Dave Good afternoon, everyone and welcome to our fourth quarter and year end 2023 earnings call.

Speaker Change: Although 2023 post numerous challenges for our organization. We are excited about our prospects in 2024, which we believe to be a pivotal year marked by a number of important clinical readouts across our oncology pipeline and continued growth of our <unk> franchise.

Thane Wedeck: This includes approximately 60,000 PDAC patients in the U.S. There is an overall 5-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. On slide 7, we provide an overview as to why we believe PAM Revlimab can provide benefits to patients diagnosed with pancreatic cancer. Based on preclinical data, CTGF plays an important role in the growth and progression of pancreatic tumors.

Speaker Change: On today's call I will focus our stakeholders on the four strategic pillars shaping our company's future trajectory. Additionally.

Speaker Change: Additionally, I'll offer insights into the progress of our Pam rebel Mab and rocks do step programs, Dr. John Hunter, Our Chief Scientific Officer will then review our exciting oncology pipeline last one Gram our CFO will review the financials after which we will open the call for your questions.

Starting on slide three fiber churn has four key strategic pillars that we believe offer significant value today.

Speaker Change: First as Pam rebel map, where we are expecting readouts from two pivotal phase III studies in pancreatic cancer in the coming months and.

Thane Wedeck: Mouse pancreatic tumor studies have shown that PamrevoMap 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 8, 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. Almost 90% of these 75 patients were in fact metastatic, with only nine having locally advanced disease. Pemrevomab 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.

Speaker Change: In January we announced the graduation and completion of the Pam rebel Mab arm and precision promise pancreatic cancer action network space two three adaptive platform trial for metastatic pancreatic cancer, where we are where we anticipate top line data in the second quarter of this year.

Speaker Change: We are now anticipating topline data from our ongoing LAPIS phase III trial in locally advanced pancreatic cancer in the second quarter of 2024 as well.

Speaker Change: Pancreatic cancer is a disease with substantial unmet medical need and represents a significant commercial opportunity for Pam rebel Mab, which is demonstrated effect in both preclinical and early clinical studies, which we will detail in a moment.

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

Thane Wedeck: The most notable result in this study was that one-year survival was 37 percent for patients who had circulating PAMREVIMAB levels of 150 micrograms per mL or higher versus 11 percent for those with lower plasma levels. These results in the higher dose cohort patients included improved median overall survival and improved median progression-free survival. Moving to slide 9.

Speaker Change: Today, we announced that Biogen has regained the rights to <unk> from our partner Astrazeneca in the U S. In <unk> territories, excluding China and South Korea. This allows us the opportunity to potentially partner <unk> in certain indications with high unmet needs such as anemia in Myelodysplastic syndromes, which I will.

Speaker Change: Touch on later in the call.

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

Thane Wedeck: Pivotal trials are being conducted with pemRevlimab in both locally advanced and metastatic patients. These patients represent almost 90% of all diagnosed pancreatic cancer patients today, giving PAMREVOMAB the potential opportunity to treat a vast majority of patients across this devastating disease. Moving to slide 10.

Speaker Change: FG 30 to 46 is a first in class potent antibody drug conjugate or ADC for the treatment of metastatic castrate resistant prostate cancer.

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

Speaker Change: We anticipate releasing additional data from our <unk> $32 46 phase one monotherapy trial in the coming weeks. In addition to FG $32 46, we're also undertaking IND, enabling activities on two innovative oncology antibodies with the intention of filing an IND for.

Thane Wedeck: In January, we announced the completion of the PAM Revlimab arm and the precision promise of the Pancreatic Cancer Action Network's Phase 2-3 Adaptive Platform Trial for Metastatic Pancreatic Cancer, which evaluates PAMREVIMAB in combination with the chemotherapy treatments gemcitabine and nabpaclitaxel for patients with metastatic pancreatic ductal adenocarcinoma. The PRECISION PROMISE trial is a Phase 2, 3 registrational study that is being conducted at the top pancreatic cancer centers in the United States. The primary endpoint of the Precision Promise trial is overall survival. PAM Revlimab is being evaluated as both first and second line therapy for metastatic disease. Moving to slide 11.

Speaker Change: <unk> <unk> 31, 65, our anti collected nine monoclonal antibody in the first quarter of 2024, and FG 31, 75, our anti <unk> monoclonal antibody in 2025.

Speaker Change: The fourth pillar is our strong cash position, we finished the year with approximately $248 1 million in cash cash equivalents and accounts receivable.

Speaker Change: In the fourth quarter, one quarter earlier than expected, we successfully executed on our company wide cost reduction plan, which.

Speaker Change: Which provides us with the ability to achieve several key milestones across our portfolio.

Speaker Change: We have taken the necessary steps to improve our strong financial position and we will continue to focus on financial discipline.

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 at <unk>. We believe that we have a strong foundation to drive significant shareholder value creation.

Thane Wedeck: The Precision Promise Study is comprised of two stages. In the initial stage of the study, or stage one, at least 100 patients with metastatic pancreatic cancer received pemrevomab in combination with gemcitabine and nabpaclitaxel. Guided by Bayesian principles, the graduation threshold for PAM-Revlimab 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 PAM-Revlimab arm successfully graduated to stage 2 in the third quarter of 2022, and an additional 75 patients were enrolled, receiving the same PAM-Revlimab treatment regimen as 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: <unk> today and into the future.

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.

Speaker Change: And having been studied in over 1000 patients across various conditions are favorable adverse event and safety profile.

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

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.

Thane Wedeck: The Pam Revlimab arm of the study completed stage two of the trial last month in January of 2024. PAMREVIMAB is the first experimental arm in the PRECISION PROMISE trial to meet its required threshold for graduation to Stage 2, and we now expect to report top-line data on 213 PAMREVIMAB-treated metastatic pancreatic cancer patients next quarter. On slide 12.

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 therapy therapeutic advances for quite some time.

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 CTG up plays an important role in the growth and progression to pancreatic tumors.

Speaker Change: <unk> pancreatic tumor studies have shown that <unk> 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.

Thane Wedeck: 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 PamrevoMab to placebo in combination with standard of care chemotherapy. The primary endpoint is overall survival, and we now expect top-line data from the study in the second quarter of 2024. As LAPIS is an event-driven trial, we have revised our timing based upon the latest information available to us. Since our last update, the pace of events has decreased, which is a common occurrence in this type of oncology study. We are currently waiting for a sufficient number of events to lock the database and will continue to provide regular updates to our stakeholders as the study nears completion. Moving to slide 13, we show a snapshot of both Pam Revlimab Registrational Phase 3 studies. One important difference between the two studies is the dosing regimen of the PRECISION PROMISE study. Pemrevomab is dosed in 28-day treatment cycles until disease progression or discontinuation, which is distinct from lapis, in which Pemrevomab was delivered in a neoadjuvant setting and where it was dosed for up to six months.

Speaker Change: Moving to slide eight 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.

Speaker Change: 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 <unk> and there are lots of nib as first line therapy.

Speaker Change: 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 the most notable result in this study was that one year survival was 37% for patients.

Speaker Change: Who had circulating <unk> levels of 150 micrograms per ml or higher versus 11% for those with lower plasma levels.

Speaker Change: These results in the higher dose cohort patients included improved median overall survival and improved median progression free survival.

Speaker Change: Moving to slide nine pivotal trials are being conducted with Pam rebel map in both locally advanced and metastatic patients.

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

Thane Wedeck: 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 PAM-Revlimab treatment. On slide 14, we review the U.S. commercial opportunity for PamrevoMab and 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: Moving to slide 10.

Speaker Change: In January we announced the completion of the <unk> arm and precision promise pancreatic cancer action network's phase two three adaptive platform trial for metastatic pancreatic cancer, which evaluates <unk> in combination with the chemotherapy treatments gemcitabine and Nab paclitaxel for patients with metastatic pancreatic.

Speaker Change: Ductal adenocarcinoma.

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

Thane Wedeck: Using straightforward assumptions, the total addressable market for pancreatic cancer in the U.S. represents a multi-billion dollar opportunity for pembrevomab if it can demonstrate a significant improvement in overall survival in either locally advanced or metastatic patients. In fact, metastatic pancreatic cancer alone represents a larger market opportunity in the U.S. for Pamrevelmab than we were previously forecasting for the IPF indication. Looking ahead, we expect results from both the Pancreatic Cancer Action Network's Precision Promise Registrational Adaptive Platform Trial evaluating pem-revo-mab and metastatic pancreatic cancer and from the LAPIS Phase III study in locally advanced disease in the second quarter of 2024. Moving out of Roxadustat and slide 16.

Speaker Change: The primary endpoint of the precision promise trial is overall survival.

Speaker Change: <unk> is being evaluated in both first and second line therapy for metastatic disease.

Speaker Change: Moving to slide 11.

Speaker Change: The precision promise study is comprised of two stages.

Speaker Change: In the initial stage of the study or stage, one at least 100 patients with metastatic pancreatic cancer receive <unk> in combination with Gemcitabine and Nab Paclitaxel.

Speaker Change: Guided by Bayesian principles, the graduation threshold for Pam rebel Mab was a protocol pre specified and greater than or equal to 35% predicted probability of success for the primary endpoint of overall survival at the completion of the trial.

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

Speaker Change: Receiving the same Pam rebel mab treatment regimen as in stage one.

Speaker Change: All patients were dosed until disease progression in the final analysis is based upon the data collected for all patients up to 12 months after the last patient initiated treatments the.

Thane Wedeck: Roxas Justec continues to perform extremely well in China, where it is indicated for anemia of chronic kidney disease. Full year 2023 total Roxydustat net sales in China by FibroGen and the distribution entity jointly owned by FibroGen and AstraZeneca were $284.1 million compared to $208.8 million a year ago, an increase of 36 percent. This growth was driven by an increase in volume of 41 percent.

Speaker Change: The <unk> arm of the study completed stage two of the trial last month in January of 2024.

Speaker Change: <unk> is the first experimental arm and the precision promise trial to meet this required threshold for graduation to stage two and we now expect to report topline data on 213, <unk> treated metastatic pancreatic cancer patients next quarter.

Speaker Change: On slide 12.

Speaker Change: We provide an overview of the global phase III LAPIS trial at.

Speaker Change: A double blind placebo controlled trial in 284 patients with locally advanced Unresectable pancreatic cancer.

Thane Wedeck: Fourth quarter total ROXADUCE net sales in China by FibroGen and the distribution entity jointly owned by FibroGen-NAZ were $66.5 million, compared to $53.1 million in the fourth quarter of 2022, an increase of 25%. This growth was driven by an increase in volume of 36%. In July 2023, our supplemental new drug application for OxyDustat in patients with chemotherapy-induced anemia was accepted by the China Health Authority, and we continue to expect an approval decision in mid-2024. If approved, FibroGen would receive a $10 million milestone payment from AstraZeneca. We believe this indication represents a meaningful incremental net revenue opportunity on top of the anemia of CKD indication. Moving to slide 17.

Speaker Change: Comparing <unk> to placebo in combination with standard of care chemotherapy.

Speaker Change: The primary endpoint is overall survival and we now expect top line data from this study in the second quarter of 2024.

Speaker Change: As LAPIS is an event driven trial, we have revised our timing based upon the latest information available to us.

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

Speaker Change: We are currently waiting for a sufficient number of events to lock the database and we will continue to provide regular updates to our stakeholders as the study nears completion.

Speaker Change: Moving to slide 13, we show a snapshot about Pam rebel Mab Registrational phase III studies one.

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.

Speaker Change: Which is distinct from LAPIS, and which Pam <unk> was delivered in the neo adjuvant setting and where it was dosed for up to six months, we believe the ability to dose patients until disease progression in the metastatic setting provides the potential opportunity to amplify clinically meaningful increases in overall survival driven by those patients benefiting from Pam <unk>.

Thane Wedeck: RoxaduceDeck continues to expand its category leadership in brand value share in China, rising to 42% in the most recent three-month period ending in December of 2023. The potential addition of the chemotherapy-induced anemia indication would create a meaningful catalyst for both continued share and volume growth of roxidustat in China. 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.

Speaker Change: <unk> treatment.

Speaker Change: On Slide 14, we review the U S commercial opportunity for <unk> in pancreatic cancer.

Speaker Change: 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: Using straightforward assumptions the total addressable market for pancreatic cancer in the U S represents a multibillion dollar opportunity for Pam rebel map if it can demonstrate a significant improvement in overall survival and either locally advanced or metastatic patients in fact, metastatic pancreatic cancer alone represents a larger market.

Thane Wedeck: Generic players face lead time and execution risk of market adoption after approval, as they need to be admitted into individual 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.

Speaker Change: <unk> in the U S for Pam rebel Mab than we were previously forecasting for the IPF indication.

Looking ahead, we expect results from both the pancreatic cancer action network precision promise Registrational adaptive platform trial evaluating <unk> in metastatic pancreatic cancer and from the LAPIS Phase III study in locally advanced disease in the second quarter of 2024.

Thane Wedeck: Despite the expiration of our composition of matter patents in June 2024, we do not expect meaningful deterioration of the rocks of business in the near term. In addition to the continued outstanding performance of Roxadustat in China, the Roxadustat launch in Europe is accelerated, showing robust quarter-over-quarter growth. We expect this growth to continue to accelerate, given the fact that RoxyZusta 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 DaprDustat, RoxasDustat maintains its strong competitive position in the EU.

Speaker Change: Moving now to <unk> on slide 16.

Speaker Change: <unk> continues to perform extremely well in China, whereas it where it is indicated for anemia of chronic kidney disease.

Speaker Change: Full year 2023, total <unk> net sales in China by <unk> and the distribution entity jointly owned by <unk> and Astrazeneca was $284 1 million compared to $208 $8 million a year ago, an increase of 36%. This growth was driven by an increase in <unk>.

Speaker Change: Volume of 41%.

Speaker Change: Fourth quarter total <unk> net sales in China by <unk> and the distribution entity jointly owned by fiber Gen. Z was $66 5 million compared to $53 1 million in the fourth quarter of 2022, an increase of 25%. This growth was driven by an increase in volume of 36%.

Thane Wedeck: Of note, we have recently been successful in defending Roxaducat's patent portfolio and now believe we have exclusivity into 2036, positioning Roxadustat to continue its growth and market leadership over the next decade plus in the EU. Moving to slide 18, today we announced that AstraZeneca returned all U.S. ROW-Roxas-Zustat rights to FibroGen, with the exception of South Korea and China. FibroGen's collaboration agreement with AstraZeneca, Paroxys, and Dustat in China remains in place, regaining the rights to Roxas Eustat in the U.S. ROW territory allows us to pursue ruxidustat development opportunities with potential partners and indications such as anemia associated with myelodysplastic syndrome. On slide 19, we highlight the potential opportunity for Roxidustat in patients with anemia associated with 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 look forward to initiating partnership discussions for Roxadustat immediately. Moving on to slide 20. In December, we presented data from the Phase 3 Matterhorn study of roxidustat in patients with anemia of lower risk mild dysplastic syndromes at the American Society of Hematology annual meeting.

Speaker Change: In July of 2023, our supplemental new drug application for <unk> in patients with chemotherapy induced anemia was accepted by the China Health Authority and we continue to expect an approval decision in mid 2024 <unk>.

Speaker Change: If approved <unk>.

Speaker Change: <unk> would receive a $10 million milestone payment from Astrazeneca.

Speaker Change: We believe this indication represents a meaningful incremental net revenue opportunity on top of the anemia of <unk> indication.

Moving to slide 17.

Speaker Change: <unk> continues to expand this category leadership and brand value share in China.

Speaker Change: Rising to 42% in the most recent three month period ending in December of 2023.

Speaker Change: The potential addition of the chemotherapy induced anemia indication would create a meaningful catalyst to both continued share and volume growth of <unk> 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 exclusivity of <unk>.

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

Speaker Change: Generic players face lead time and execution risk of market adoption after approval.

Speaker Change: They need to be admitted into individual 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.

Thane Wedeck: Although we missed the primary endpoint of transfusion independence, 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 Roxidustat represents an important potential therapy for patients in the U.S. and other territories where it has not yet been approved. I will now hand it off to John Hunter, our CSO, to discuss our early stage pipeline. John?

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 a business in the near term.

Speaker Change: In addition to the continued outstanding performance of <unk> in China. The rocks just at launch in Europe is accelerated showing robust quarter over quarter growth.

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

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

John Hunter: Thank you, Thane. Moving to slide 22, a snapshot of our early stage oncology pipeline consisting of one phase two ready ADC program for metastatic castration resistant prostate cancer and two preclinical immuno-oncology programs. For today's call, I will be focusing on FG3246, a CD46-directed antibody drug conjugate in development for metastatic prostate cancer and potentially other solid tumors, to briefly address our immuno-oncology program. We anticipate an IND filing for FG3165, our Galectin-9 targeted antibody that prevents Gal-9 mediated immune suppression later this quarter. We are currently performing IND enabling activities for FG3175, our anti-CCR8 antibody for depletion of tumor infiltrating T regulatory cells, and expect to file an IND in 2025. Slide 23 is an overview of FG3246. FG3246 is a potential 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 at high levels in prostate cancer and other tumor types, but that demonstrates very limited expression in most normal tissues, making it an ideal ADC target candidate.

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

Speaker Change: Of note we have recently been successful in defending <unk> patent portfolio and now believe we have exclusivity into 2036 positioning <unk> to continue its growth and market leadership.

Speaker Change: The next decade, plus in the EU.

Speaker Change: Moving to slide 18 today, we announced that Astrazeneca returned all U S. <unk> rights to <unk> with the exception of South Korea, and China fiber.

Speaker Change: <unk> collaboration agreement with Astrazeneca for <unk> in China remains in place.

Speaker Change: Regaining the rights to <unk> in the U S. R. O W. Territories allows us to pursue <unk> development opportunities with potential partners in indications such as anemia associated with Myelodysplastic syndromes.

Speaker Change: On slide 19, we highlight the potential opportunity for <unk> in patients with anemia associated with Mds.

Speaker Change: There is a well defined patient population and a clear clinical need given the current therapeutic alternatives, which translates into a significant significant commercial opportunity.

Speaker Change: We look forward to initiating partnership discussions for rocks do that immediately.

Speaker Change: Moving on to Slide 20 in December we presented data from the Phase III Matterhorn study of <unk> in patients with anemia of lower risk Myelodysplastic syndromes at the American Society of Hematology annual meeting.

Speaker Change: Although we missed the primary endpoint of transfusion independence, <unk> demonstrated a numerical advantage relative to placebo.

John Hunter: Moving to slide 24, FG3246 is comprised of an anti-CD46 antibody, YS5, linked to the anti-mitotic agent, MMAE, which is a clinically and commercially validated ADC payload. FG3246 has demonstrated efficacy against CD46-expressing tumors in both preclinical and clinical studies, and an associated PET imaging biomarker, PET46, utilizes the same targeting antibody as FG3246 It is comprised of the YS5 antibody coupled to the radionuclide zirconium-89, and in preclinical studies, it demonstrates specific targeting of and uptake by CD46 positive tumors. We plan to explore its potential use for identifying FG3246 responsive patients in a phase two trial that I will touch upon shortly. Moving to slide 25.

Speaker Change: 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> <unk>.

Speaker Change: Versus placebo base.

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: I will now hand, it off to John Hunter, our CFO to cover our early stage pipeline John Thank you thing move.

John Hunter: Moving to slide 22, and a snapshot of our early stage oncology pipeline, consisting of one phase II ready ADC program for metastatic castration resistant prostate cancer and two preclinical immuno oncology programs for today's call I will be focusing on FTE $32 46, a CD 46.

John Hunter: Directed antibody drug conjugate in development and development for metastatic prostate cancer and potentially other solid tumors to briefly address our immuno oncology programs.

John Hunter: We anticipate an IND filing per FTE 31, 65 are collected nine targeted antibody that prevents <unk> mediated immune suppression later this quarter.

John Hunter: As we have stated in previous earnings calls, FG3246 has demonstrated monotherapy clinical efficacy in multiple myeloma and metastatic castration-resistant prostate cancer. Interim data presented at ASCO 2022 from the Phase 1 trial in prostate cancer showed that 4 out of 21 evaluable patients had partial responses based on resistance criteria at the two highest study doses. It also showed a PSA-50 response rate of 45% in heavily pretreated patients who had a median of five prior therapies. The safety profile for FG3246 was consistent with other MMAE-based ADC therapeutics, with neutropenia being the most common adverse event.

John Hunter: We are currently performing IND, enabling activities for FTE $31 75, our anti <unk> antibody for depletion of tumor infiltrating T regulatory cells and expect to file an IND in 2025.

John Hunter: On slide 23 is an overview of FTE 30 to 46 ft $32 46, as a potential first in class ADC for metastatic castration resistant prostate cancer colorectal cancer and other tumor types.

John Hunter: FTE $32 46 binds to a cell receptor target that internalizes upon antibody binding and is present at high levels in prostate cancer and other tumor types, but that demonstrates very limited expression in most normal tissues, making it an ideal ADC target candidate.

John Hunter: Additional data from this recently completed Phase 1 trial will be reported later this quarter. On slide 26, we show ongoing and planned clinical trials for FG3246. In addition to the phase one dose escalation and expansion study referenced on the previous slide, there is also a combination study with endelutamide that is currently being run at UCSF. The rationale for this combination is based on preclinical data demonstrating upregulation of CD46 in tumor cells following enzalutamide treatment, therefore potentially making them more responsive to treatment with FG3246. Interim data from this trial is expected in mid-2024. A trial for the PET-46 biomarker in prostate cancer is in progress at UCSF.

Moving to slide 24, FTE $32 46 is comprised of an anti CD 46 antibody y S. Five linked to the anti mitotic agent and then AE, which is a clinically and commercially validated ADC payload.

John Hunter: FTE $32 46 has demonstrated efficacy against CD 46, expressing tumors in both preclinical and clinical studies.

John Hunter: And associated pet imaging biomarker at 46 utilizes the same targeting antibody as FTE $32 46, and is under clinical development at UCSF. It is comprised of the lightest five antibody coupled to the radionuclide zirconium 89 and in preclinical studies.

John Hunter: Straight specific targeting of an uptake by CD 46 positive tumors, we plan to explore its potential use for identifying FG $32 46 responsive patients in a phase II trial that I will touch upon shortly.

John Hunter: The goal is to develop a screening assay to select patients with high CD46 expression who are most likely to benefit from treatment with FG3246. The biomarker will be part of a phase 2 study run by FibroGen in which approximately 100 patients will be enrolled following a PET scan with PET46. Patients will not be stratified at the start of the study, but the correlation between PET positivity and FG32-46 efficacy will be assessed at the end of the study with the potential to use the PET-46 biomarker to stratify patients in a pivotal phase three trial. We anticipate the initiation of the phase 2 trial in metastatic castration-resistant prostate cancer in the second half of 2024. I will now turn the call over to Juan Graham to discuss the company's financials. Okay, Juan?

John Hunter: Moving to slide 25.

John Hunter: As we have stated in previous earnings calls FTE $32 46 has demonstrated monotherapy clinical efficacy in multiple myeloma in metastatic castration resistant prostate cancer.

John Hunter: Interim data presented at <unk> 2022 from the Phase one trial in prostate cancer showed that four out of 21 Evaluable patients had partial responses based on resist criteria at the two highest study doses.

John Hunter: It also showed a PSA 50 response rate of 45% in heavily pretreated patients who had a median of five prior therapies.

John Hunter: The safety profile for FTE 30 to 46 with consistent with other MMA based ADC therapeutics with neutropenia being the most common adverse event.

Juan Graham: Thank you, John. Before providing our financial update, I would like to remind everyone that full financial results are in a press release and the recently filed 10K. I will begin my remarks with a revenue summary for both full year 2023 and fourth quarter of 2023, subsequently providing financial performance detail on our China business for 2023, along with 2024 guidance for our China operation. Finally, I will wrap up with operating expense results and our cash out. For the full year 2023, total revenue was $147.8 million compared to $140.7 million for the same period in 2022, an increase of 5% year over year. These figures highlight the sustainability of the revenues from our Roxa Dustec franchise as we have transitioned from higher development and licensed revenue in 2022 to higher commercial revenue in 2023. For the fourth quarter of 2023, total revenue was $27.1 million compared to $34.4 million for the same period in 2022. The fourth quarter $7.3 million year-over-year revenue reduction was primarily driven by shipment timing of drug product revenue to a status of $5.4 million.

John Hunter: Additional data from this recently completed phase one trial will be reported later this quarter.

John Hunter: On slide 26, we show ongoing and planned clinical trials for FTE $32 46.

John Hunter: In addition to the phase one dose escalation and expansion study referenced on the previous slide. There is also a combination study with <unk> that is currently being run at UCSF.

John Hunter: The rationale for this combination is based on preclinical data demonstrating upregulation of <unk> 46 in tumor cells following <unk> treatment.

John Hunter: Therefore, potentially making them more responsive to treatment with FG $32 46.

John Hunter: Interim data from this trial is expected in mid 2024.

John Hunter: A trial for the 46 biomarker in prostate cancer is in progress at UCSF. The goal is to develop the screening assay to select patients with high <unk> 46 expression, who are most likely to benefit from treatment with FG $32 46.

The biomarker will be part of the phase two study run by fibrinogen in which approximately 100 patients will be enrolled following a pet scan with <unk> 46.

John Hunter: Patients will not be stratified at the start of the study, but the correlation between pet positivity and FTE 30 to 46 efficacy will be assessed at the end of the study with the potential to use the pet 46 biomarker to stratify patients in a pivotal phase III trial we.

Juan Graham: Reduction of development revenue from our Rockford-Eustat partners of $1.9 million and from changes in the assumptions of our China Single Performance Obligation Model, which adjusts prior and future revenue for changes in many variables, such as forecasted future volume sold, forecasted future price, and forecasted foreign exchange amongst other assumptions, diving deeper into the financial performance of our business in China. 2023 full-year net sales of RoxaDusta by FibroGen and the Joint Distribution Entity (JDE) owned by AstraZeneca and FibroGen were $284.1 million compared to $208.8 million in 2022, a significantly healthy growth of 36% year-over-year. In Q4 2023, FibroGen and JDE net sales were $66.5 million compared to $53.1 million in the fourth quarter of 2022, an increase of 25.2% year over year. Q4 revenue reflects distributor inventory adjustments due to the renewed NRDL price, representing an impact of $5.3 million or a 10% impact on growth year-over-year.

John Hunter: We anticipate the initiation of the phase III trial in metastatic castration resistant prostate cancer in the second half of 2024.

Speaker Change: I'll now turn the call over to one gram to discuss the company's financials one.

One Gram: Thank you John.

One Gram: We're providing our financial update I would like to remind everyone that full financial results are in our press release and our recently filed 10-K.

One Gram: I will begin my remarks with a revenue summary for both full year 2023, and fourth quarter of 2023 subsequently providing financial performance detail in our China business for 2023, along with 2024 guidance for China operations.

One Gram: Finally, I will wrap up with operating expense results in our cash outlook.

One Gram: For the full year 2023, total revenue was 147 $8 million compared to $147 million for the same period in 2022, an increase of 5% year over year. These.

One Gram: These figures highlight the sustainability of the revenues from our Rockford do step franchise.

One Gram: As we have transitioned from higher development and license revenue in 2022 to higher commercial revenue in 2023.

One Gram: For the fourth quarter of 2023 total revenue was $27 1 million compared to $34 4 million for the same period in 2022.

One Gram: The fourth quarter of $7 $3 million a year over year revenue reduction was primarily driven by shipment timing of drug product revenue to astellas of $5 4 million.

Juan Graham: As a reminder, a recent inclusion in the 2023 NRDL list came with a 7% price reduction. The sales performance of Roxadusta in China substantiates the achievement of the highest value share since launch at 42% of the category in Q4 2023. From total ROXADUCE.NET sales in China, FibroGen's net transfer price from sales to the JDE was $88.6 million and $21.3 million for the full year of 2023 and Q4 2023, respectively.

Reduction of development revenue from our <unk> partners of $1 9 million.

One Gram: And from changes in the assumptions of our China single performance obligation model, which adjusts prior and future revenue for changes in many variables such as forecasted future volume sold forecasted future price and forecasted foreign exchange amongst other assumptions.

One Gram: Diving deeper on the financial performance of our business in China.

One Gram: 2023 full year net sales of <unk> by fiber, Jim and the joined distribution entity or J D. E owned by Astrazeneca and fiber, Jim was $284 $1 million compared to $208 8 million in 2022.

Juan Graham: This compares to $68.8 and $17.2 million for the full year and fourth quarter of 2022, respectively, an increase of 28.8% in full year 2023 and 23.8% in the fourth quarter of 2023. As a reminder, the net transfer price is the best approximation of FibroGen's portion of the cash in our China operation. As a result, for a full year 2023, FibroGen recorded $89 million in net revenue from Roxa-Dustat sales to the JDE and $11.9 million of direct-to-distributors sales from FibroGen China, totaling $100.9 million on a U.S. GAAP basis.

One Gram: A significantly healthy grow.

One Gram: Growth of 36% year over year.

One Gram: In Q4, 2023 fiber M. J D E net sales were $66 $5 million compared to $53 $1 million in the fourth quarter of 2022.

One Gram: An increase of 25, 2% year over year.

One Gram: Q4 revenue reflects distributor inventory adjustment due to the renewed and our deal price, representing an impact of $5 3 million or a 10% impact from growth year over year.

One Gram: As a reminder, our recent inclusion into the 2023 and our deal came with a 7% price reduction.

One Gram: The sales performance of <unk> studying China substantiate the achievement of the highest value share since launch at 42% of the category in Q4 2023.

One Gram: From total rux reduced that net sales in China fiber Jensen that transfer price from sales to the J D. E was $88 6 million and $21 $3 million for the full year of 2023 in Q4 2023, respectively.

Juan Graham: For Q4 2023, FibroGen revenue from Roxadustep sales to the JDE was $20.7 million, and $2.8 million of direct-to-distributor sales from FibroGen China, totaling $23.5 million in the U.S. gap base. Our revenue growth highlights the continuous robustness in commercial execution and physician and patient adoption of ruxidustat in China. For full year 2024, we are forecasting FibroGen China product revenue to be between $120 to $135 million on a US gap basis, which assumes an underlying forecast of RoxaDustat net sales in China to range from $300 to $340 million. Now moving down the income statement, our operating costs and expenses for the fourth quarter of 2023 were $81.3 million compared to $100.5 million for the fourth quarter of 2022, a decrease of $19. Approximately 65% or $51.7 million of our operating expenses were for R&D expenses.

One Gram: This compared to $68 eight and $17 2 million for the full year and fourth quarter of 2022, respectively.

One Gram: An increase of 28, 8% and full year 2023, and 23, 8% in the fourth quarter of 2023.

One Gram: As a reminder, net transfer price is the best approximation of fiber portion of the cash in our train operations.

One Gram: As a result for full year 2023 fiber Gen recorded $89 million in net revenue from <unk> sales to the JV and $11 $9 million of direct to distributor sales from fibers in China totaling $109 million on a U S GAAP basis.

One Gram: For Q4, 2023 fiber Gen revenue from rest of the <unk> sales through the JV was $20 7 million and $2 $8 million of direct to distributor sales from fibers in China totaling $23 $5 million in the U S GAAP basis.

One Gram: Our revenue growth highlights the continuous robustness and commercial execution and physician and patient adoption of <unk> in China.

One Gram: Yeah.

One Gram: For full year 2024, we are forecasting fiber Gen train up product revenue to be in the to be between $120 million to $135 million in the U S GAAP basis.

One Gram: Which assumes an underlying forecasts a Brexit <unk> net sales in China to range from $300 million to $340 million.

One Gram: Now moving down the income statement, our operating costs and expenses for the fourth quarter of 2023 were $81 3 million compared to $105 million for the fourth quarter of 2022.

Juan Graham: Of this, approximately 59% was related to Pemreblumab, 32% allocated to support our early stage pipeline, and the remaining 9% directed towards Ruxedusta development activities in the United States and China. During the fourth quarter of 2023, we recorded a net loss of $56.2 million, or $0.57 net loss per both basic and diluted share, as compared to a net loss of $66.2 million, or $0.70 per basic and diluted share for the fourth quarter of 2022. On slide 28, we highlight our performance against our prior savings guidance. I am pleased to announce that we have successfully achieved our cost reduction plan of approximately $120 million in total annualized expenses, or approximately $30 million per quarter, one quarter earlier than expected. We now forecast our total operating expenses, including COGS, to be between 70 to 80 million dollars per quarter for the first half 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 pembromial and pancreatic cancer. Now shifting towards cash, as of December 31, we reported $248.1 million in cash, cash equivalents, investments, and accounts receivable.

One Gram: A decrease of $19 $2 million year over year, reflecting a reduction in expenses as previously communicated through clinical trials shutdowns SG&A efficiencies in the U S head count reductions.

One Gram: Approximately 65% or 51 7 million so for operating expenses Watson R&D expenses.

Of this approximately 59% was related to <unk>, 32% allocated to support of our early stage pipeline and the remaining 9% directed towards development activities in the United States and China.

One Gram: During the fourth quarter of 2023, we recorded a net loss of $56 2 million or <unk> 57, net loss per both basic and diluted share.

One Gram: As compared to a net loss of $66 $2 million or <unk> 70 per basic and diluted share for the fourth quarter of 2022.

One Gram: On slide 28, we highlight our performance against our prior savings guidance.

One Gram: I am pleased to announce that we have successfully achieved our cost reduction plan of approximately $120 million in total annualized expenses were approximately $30 million per quarter, one quarter earlier than expected.

One Gram: We now forecast, our total operating expenses, including Cogs.

One Gram: To be between $70 million to $80 million per quarter for the first half of 2024.

One Gram: 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.

Now shifting towards cash.

One Gram: <unk> 31, we reported $248 $1 million in cash cash equivalents investments and accounts receivable.

Juan Graham: As we move forward, we expect our quarterly cash burden rate to reflect the reduction in operating expenses that we have been able to successfully achieve. 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. Thank you. And now I would like to turn the call back over to, Juan. In closing, we are excited about our near-term prospects and the potential value they could provide to stakeholders.

One Gram: As we move forward, we expect our quarterly cash burn rate to reflect the reduction in operating expenses that we have been able to successfully achieve.

One Gram: 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 plan into 2026.

Speaker Change: Thank you.

Speaker Change: And that would like to turn the call back over to me.

Speaker Change: Thanks Juan.

Speaker Change: In closing we are excited about our near term prospects and the potential value. They provide our stakeholders to recap we expect topline data from the following two <unk> pivotal studies.

Thane Wedeck: To recap, we expect top-line data from the following two PemRevelMap pivotal studies. The Phase 2-3 Pancreatic Cancer Action Network Precision Promise Trial in Metastatic Pancreatic Cancer in the second quarter of 2024 and the Phase 3 LAPIS Trial in Locally Advanced Pancreatic Cancer also in the second quarter of 2024. Roxazustat continues to perform very well in China, where our SNDA has been accepted for the chemotherapy-induced anemia indication, and our partner Astellas continues with the commercialization of Roxazustat in Europe, Additionally, we are excited to regain the rights to Roxas-Dustat in U.S. ROW territories from AstraZeneca, and we'll be exploring potential partnering opportunities in MDS. With our early stage pipeline, we expect additional data from the phase one monotherapy study of FG3246 in metastatic castration-resistant prostate cancer later this quarter.

Speaker Change: <unk> II <unk> III pancreatic cancer action network precision promise trial in metastatic pancreatic cancer in the second quarter of 2024, and the phase III LAPIS trial in locally advanced pancreatic cancer also in the second quarter of 2024.

Speaker Change: <unk> continues to perform very well in China, where our <unk> NDA has been accepted for the chemotherapy induced anemia indication and our partner Astellas continues with the commercialization of <unk> in Europe, Japan and other markets.

Speaker Change: Additionally, we are excited to regain the rights for <unk> for U S. <unk> territories from Astrazeneca, and we will be exploring potential partnering opportunities in Mds.

Speaker Change: With our early stage pipeline, we expect additional data from the phase one monotherapy study of FG $32 46 in metastatic castration resistant prostate cancer. Later this quarter, we anticipate the initiation of a phase II trial NMC RPC in the second half of 2024, we.

Thane Wedeck: We anticipate the initiation of a phase two trial in MCRPC in the second half of 2024. Additionally, we anticipate filing an IND for FG3165, our anti-Gal-9 antibody, in the first quarter of 2024. 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.

Speaker Change: We anticipate filing an IND.

For FG 31, 65, our anti <unk> antibody in the first quarter of 2024.

Speaker Change: And we anticipate filing an IND for FG 31, 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 Wedeck: 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 ROXADUSTAT revenue stream, near-term PAM-Revlimab readouts in pancreatic cancer, our oncology pipeline, and our strong balance sheet. I would like to thank all the employees of FibroGen for their continued hard work and perseverance over the last few months. I would now like to turn the call over to the operator for Q&A.

Speaker Change: 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 <unk> revenue stream.

Speaker Change: Near term <unk> readouts in pancreatic cancer.

Speaker Change: Our oncology pipeline and our strong balance sheet.

Speaker Change: I would like to thank all the employees of fibers and for their continued hard work and perseverance over the last few months.

Speaker Change: I would now like to turn the call over to the operator for Q&A.

Thane Wedeck: Thank you. Again, ladies and gentlemen, if you'd like to ask a question, please press star 1-1 on your touch-tone telephone. Again, to ask a question, please press star 1-1 on your touch-tone telephone. Star 1, One moment for our first. Our first question comes from the line of Andy Hsieh of William and Mary Lines.

Speaker Change: Thank you.

Speaker Change: Again, ladies and gentlemen, if you'd like to ask a question. Please press star one on your Touchtone telephone again to ask a question. Please press star one one.

Speaker Change: One moment for our first question.

Speaker Change: Our first question comes from the line of Andy Athene.

Andy Hsieh: William Blair Your line is open.

Andy Hsieh: Oh, great. Thanks for taking my questions.

Andy Hsieh: Oh, great. Thanks for taking my questions. You know, a very intriguing development with the Roxas-DoostDat rights, or regaining Roxas-DoostDat rights.

Andy Hsieh: Very intriguing development with the <unk> right, well regaining <unk> right.

Thane Wedeck: So starting with Roxas-DoostDat, looking at your guidance of 12% growth based on JDE revenue, combined with a price reduction, can we extrapolate that you're anticipating roughly about a 20% volume growth this year? And moving on to the CD4680C, look forward to the KOL call that you're scheduling. In the waterfall plot that was presented at ASCO 2022, there's a pretty clear dose response. I'm curious about the phase two program, at which dose you're thinking about starting. I think in the presentation, it says something about 1.2 milligrams per kilogram as the minimally efficacious dose. But I guess the dose response really was demonstrated at 2.4. Just curious about the dosing scheme that you're thinking about.

Andy Hsieh: So.

Andy Hsieh: Starting with <unk> looking at your guidance of 12% growth based on the J D E revenues can.

Combined with the price reduction so can we kind of extrapolate that.

Andy Hsieh: Anticipating roughly about a 20% volume growth this year.

Andy Hsieh: And moving on to the.

The CD 46 ADC.

Speaker Change: Look forward to the Kols call that Youre scheduling.

Speaker Change: The waterfall plot that was presented in.

Speaker Change: At Astro 2022.

Speaker Change: Pretty clear dose response.

Speaker Change: I'm curious about the phase III program.

Speaker Change: Which dose youre thinking about starting I think in the presentation. It says something about the one two milligram per kilogram.

Speaker Change: As the millet minimally efficacious dose.

Speaker Change: But I guess the dosage size really.

Speaker Change: It was demonstrated at the $2 four just curious so just curious about the dosing scheme that youre thinking about and one thing about the phase III.

John Hunter: And one thing about the phase two design, are you thinking about prophylactic GCSF administration for patients? Hey, Andy, thanks much for your question. Regarding rocks of volume growth in China, you know, I think if you were to look at kind of the midpoint of, you know, the 300 to $340 million guidance, you'd be right in that ballpark from a volume growth perspective. We did, we will, we'll be able to provide more guidance when we have clarity on the CIA indication and the approval of that indication as well. But I think that your math works out pretty well.

Speaker Change: Design are you thinking about the prophylactic G CSF administration for patients.

Speaker Change: Hey, Andy Thanks, So much for your question regarding rocks are volume growth in China.

Speaker Change: If you were to look at kind of the midpoint of the $300 million to $340 million guidance that you'd be right in that ballpark from a volume growth perspective.

Speaker Change: We will we'll be able to provide more guidance when we have clarity on the CIA indication and the approval of that indication as well.

But I think that your math works out pretty well.

Andy Hsieh: As it relates to the phase two design regarding dose and prophylactic GCSF, I'll let John handle that question. Thanks, Zane. Hi Andy, how are you?

Speaker Change: As it relates to the phase two.

Speaker Change: Design <unk>.

Speaker Change: Regarding dose in prophylactic G CSF I'll, let John handle that question.

John Hunter: Thanks, Hi, Andy how are you.

Thane Wedeck: Yeah, just with regard to your question, so the 1.2 mg per kg in the phase one trial was the dose where they saw biological activity, you know, as evidenced by the PSA-50 responses. And they did see PSA-50 responses in stable disease, escalating up to those higher doses of 2.7 and 3 mg per kg. With regard to the phase two dose, we do want to dose at what we think the highest tolerable dose is, so we're really going to try to balance the efficacy that we saw in the phase one trial along with some of the adverse event profiles that we're seeing in our analysis of the data. We will share that information probably about the time that we are presenting the results from the phase one trial. Got it. And if you don't mind, let me squeeze in one more for Pembrebomab.

John Hunter: Yes, just with regards to your question. So the one two Meg per kg in the phase one trial.

John Hunter: The dose where they saw biologic activity.

John Hunter: As evidenced by the PSA 50 responses.

John Hunter: They did see PSA 50 responses and stable disease escalating up to those higher doses.

John Hunter: $2 7 million three mix per kg.

John Hunter: With regards to the phase two dose we do want to dose what we think the highest tolerable doses. So we're really going to try to balance the efficacy that we saw in the phase one trial.

John Hunter: Along with some of the adverse event profiles that we're seeing in our analysis of the data.

John Hunter: We will share that information probably about the time that we are presenting the results from the phase one trial.

Speaker Change: Got it.

Speaker Change: If you don't mind, let me squeeze in one more for Penn verbal Matt So for the precision promise study.

Thane Wedeck: So for the precision promise study, how do the top-line results look? Will it work out? So do you have to go back to Pan Can and kind of formulate some sort of disclosure strategy, or is it up to you or it's up to them?

Matt So: How does the.

Matt So: Topline results logistics will work out so do you have to go back to patent can kind of formulate.

Matt So: Some sort of disclosure strategy or it's up to you or it's up to them.

Thane Wedeck: So just to talk about that, just to inform investors what to expect. Thank you. Yeah, good question, Andy.

Matt So: Talk about that.

Just to inform investors what to expect thank you.

Speaker Change: Yes, good question, Andy and after I answer that question I will turn it back over to John to address the G. CSF piece of your of your previous question as well.

Andy Hsieh: And after I answer that question, I'll turn it back over to John to address the GCSF piece of your previous question as well. And so, you know, because it is a PanCan-sponsored study, PanCan, in association with Berry and Associates, which is, you know, the world leader in Bayesian statistical design and analysis, they will do the analysis of the primary OS endpoint and then communicate that to us. And so, again, because they are the sponsor of the study, they're accountable for the statistical analysis plan.

Speaker Change: So.

Speaker Change: Because it is a pan can sponsored study.

Speaker Change: <unk> can will and association with with bearing associates, which is the world leader in Bayesian Statistical design and analysis. They will do the analysis of the primary OS endpoint and then communicate that to us.

Speaker Change: And so again because they are the sponsor of the study.

Speaker Change: They're accountable for the statistical analysis plan that we will be working in close collaboration with them.

Thane Wedeck: Now, we'll be working in close collaboration with them, and we're still working through some of the details as it relates to how the top-line primary OS result will be communicated. But because it is a PanCan-sponsored study, they're responsible for that. And Andy, just to address your question about prophylactic GCSF. We are looking at having prophylactic GCSF as part of the phase 2 study design. This was incorporated into the investigator-sponsored combination trial that's currently running at UCSF. And so we're looking at the results from that trial as we plan out our phase 2 and start thinking about having GCSF to prevent neutropenia in our patients. Got it. That's super helpful.

Speaker Change: We're still working through some of the details as it relates to how the top line primary OS a result will be communicated but because it is a pain can sponsor study they're responsible for that.

Speaker Change: And Andy just to address your question about the prophylactic G CSF.

Speaker Change: We are looking at having prophylactic G CSF as part of the Phase III study design.

Speaker Change: This was incorporated into the investigator sponsored combination trial that is currently running at UCSF.

Speaker Change: And so we're looking at the results from that trial as we plan out our phase two and start thinking about having gcs F to prevent neutropenia and our patients.

Speaker Change: Got it.

John Hunter: Thank you so much. Thanks, Andy. Thank you. Our next question comes from the line of Paul Choi of Goldman Sachs. Your line is open.

Speaker Change: Super helpful. Thank you so much.

Thanks, Andy.

Speaker Change: Thank you one moment please.

Speaker Change: Our next question comes from a line of Paul Choi of Goldman Sachs. Your line is open.

Paul Choi: Hi, good afternoon team and thanks for taking our questions.

Paul Choi: Good afternoon, team, and thanks for taking our questions. I have two on 3246, and I guess with the phase one monotherapy results imminent here, how would you direct investors in the industry to think about interpreting the results? Would you just focus, as you seem to be emphasizing, just on the highest doses as potentially the most therapeutically relevant here, or is the focus also on demonstrating a broader dose response? And then I had a follow-up question about the combination study. Thanks, Paul. John, do you want to go ahead and take it?

Paul Choi: Two on $32 46, and I guess.

Paul Choi: With the phase one monotherapy results eminent here I guess.

Paul Choi: How would you direct investors on the street, just sort of think about interpreting the results would you just focus.

Paul Choi: You seem to be emphasizing just on the highest dose doses as potentially the most therapeutics.

Paul Choi: Relevant here.

Paul Choi: This is a focus also on demonstrating a broader dose response, and then I had a follow up question on the on the combination study.

Speaker Change: Thanks, Paul John you want to go out and take.

John Hunter: Yeah, thanks for the question, Paul. So, in looking at the broader data set that was presented at ASCO and also what we plan on rolling out with the completed Phase 1 trial, the objective responses were all seen at the highest doses, but the PSA-50 responses, which are also considered very important in this disease, were seen down to 1.2 mg per kg. And in looking at the progression-free survival data, which we'll be sharing later this quarter, we have seen that there were some durable responses, even at some of the lower doses. So I wouldn't focus entirely on the highest doses. I would look at the broader data set.

Speaker Change: Yeah. Thanks for the question Paul So in looking at the broader dataset that was presented at <unk> and also what we plan on rolling out with the completed phase one trial.

John Hunter: The objective responses were all seeing at the highest doses, but the PSA 50 responses, which are also considered very important in this disease.

John Hunter: We're seeing down to 1.2 mix per gig.

John Hunter: And then looking at the progression free survival data, which we'll be sharing later this quarter.

John Hunter: We have seen that there were some durable responses even at some of the lower doses. So I wouldn't focus entirely on the highest doses I would look at the broader dataset.

John Hunter: Obviously, we're going to need to settle on a phase two dose that we move forward with, but as I mentioned in my previous answers, we are taking safety into account together with the efficacy that we've seen. Yeah, and Paul, maybe one other comment to add to what John said.

John Hunter: Obviously, we're going to need to settle on a phase II dose that we move forward with that as I had mentioned in my previous answers. We are taking safety into account together with the efficacy that was seen.

John Hunter: And then Paul maybe one other comment to tag on to what John said, recognizing that the phase one cohort was a heavily pre treated patient population with a median of five lines of therapy prior to receiving FG $32 46.

Thane Wedeck: Recognizing that the phase one cohort was a heavily pre-treated patient population with a median of five lines of therapy prior to receiving FGE3246, I think there are some things you can interpret relative to the phase 1 data and perhaps some things that, you know, we'll have to wait until we see the phase 2 results because we're going to be studying this in a different patient population. We're not going to be waiting for patients who have been pre-treated with that many courses of therapy prior to exposing them to FG3246.

Paul: There are some things you can interpret relative to the phase one data in <unk> and perhaps some of the things that.

Paul: We'll have to wait until we see the phase II results, because we're going to be studying this in a different patient population, we're not going to be waiting for patients who have been pretreated with that many courses of therapy prior to exposing them to FG 30 to 46.

Paul Choi: Thanks for that. And then, as a follow-up, you referenced the UCF-sponsored study in combination with Xtandi here, recognizing that study is investigator-driven and not totally in your control, but it is an earlier population. So I guess, as you think about the pending results from the monotherapy study versus potentially going in earlier lines with a combination program with Xtandi and or other agents, how is your rank order prioritizing those developments in terms of advancing to Phase II studies? Would you want to wait until you see the combination results out of UCSF?

Speaker Change: Great. Thanks for that and then as a follow up you referenced the UCF sponsored study in combination with extended here.

Speaker Change: And recognizing that the study is investigator driven and not tolerated in your control.

Speaker Change: But it isn't an earlier our population so I guess as you think about the pending results from the monotherapy study versus potentially going on earlier aligns with the combination program with Sandy and our other agents.

Speaker Change: How would you rank order prioritizing those developments.

Speaker Change: In terms of advancing to phase II studies would you want to wait till you see the see that combination results out of out of UCSF.

Thane Wedeck: Thank you so much for taking our questions. Yeah, thanks, Paul. Great question.

Speaker Change: So much for taking our questions.

Speaker Change: Yeah. Thanks, Paul Great question, we do want to see at least some of the data out of UCSF before we would prioritize that relative to the monotherapy trial.

Paul Choi: We do want to see at least some of the data from UCSF before we would prioritize that relative to the monotherapy trial. Obviously, if we do see a really, you know, decided clinical benefit with the combination, that would be a pretty high priority for us moving forward in planning our clinical trials and knowing that there's just tremendous opportunity across the entire spectrum of patients with prostate cancer. So I hope we have to make those trade-off decisions, Paul.

Obviously, if we do see really.

Speaker Change: Decided clinical benefit with the combination.

Speaker Change: That would be a pretty high priority for us moving forward and planning our clinical trials.

Speaker Change: Knowing that there is just tremendous opportunity across the entire spectrum.

Speaker Change: <unk> with with prostate cancer. So I hope we have to make those trade off decisions Paul.

Thane Wedeck: Great. Thanks so much. Thank you. One moment, please. Our next question comes from the line of Jason Gerberi of Bank of America. Your line is open. Hi, good afternoon. This is Dina An for Jason.

Speaker Change: Great. Thanks, so much.

Speaker Change: Thank you one moment please.

Speaker Change: Our next question comes from the line of Jason <unk> of Bank of America. Your line is open.

Jason: Hi, Good afternoon. This is Dan on for Dave.

Jason Gerberi: Thank you so much for taking our questions. We just had a couple on FG3246. So on the phase one top-line data, could you just frame the scope of the update in terms of patient number and duration of follow-up, and if you get, say, you know, two to four responses in this dose expansion cohort, would you consider this a favorable advancement given how heavily pretreated the patients are? And I just have one follow-up. Yeah, thanks for the question. Just with regard to the scope of the data that we'll be, you know, talking about when we release the results. We're going to focus pretty much on the same readouts that were shown at ASCO 2022 with the objective responses and the PSA-50 responses, but really, a pretty standard way of looking at data currently in metastatic castration-resistant prostate cancer is the composite response rate that includes either the PSA-50 responses or the objective responses.

Dan: Thank you so much for taking our question.

Had a couple on <unk>.

Jason: Key 30 to 46.

Jason: So in the phase one top line data could you just frame the scope of the update in terms of patient number and duration of follow up.

Speaker Change: If you get.

Speaker Change: Two to four responses in the dose expansion cohort.

Speaker Change: Consider this a favorable advancement given how heavily pretreated patients are and I just have one follow up to that.

Speaker Change: Yes. Thanks for the question just with regards to the scope of the data that we'll be.

Speaker Change: Talking about when we released the results.

Speaker Change: We're going to focus pretty much on the same readouts.

Speaker Change: Were shown at <unk>.

Speaker Change: <unk> 2022.

Speaker Change: With the objective responses in the PSA 50 responses.

Speaker Change: But really a pretty standard way of looking at data currently in metastatic castration resistant prostate cancer is the composite response rate that includes.

Speaker Change: Either the PSA 50 responses and or the objective responses.

John Hunter: One thing that we will have more mature data on will be progression-free survival. A lot of the patients who are on study at the time of ASCO obviously have extended out in terms of their treatment cycle. So we will have that data as well. In terms of what we will see as being favorable, as Thayne mentioned, this is a very heavily pre-treated group of patients. So it's hard to do direct comparisons against other drug trials because the patient populations vary.

Speaker Change: One thing that we will have more mature data on will be progression free survival.

Speaker Change: A lot of the patients who are on study at the time of Vasco obviously.

Speaker Change: Extend it out in terms of their treatment cycles. So we will have that data as well in terms of what we will see as being favorable.

Speaker Change: As <unk> mentioned this is a very heavily pretreated group.

Speaker Change: A group of patients.

Speaker Change: So it's hard to do direct comparisons against other drug trials, because the patient populations vary.

John Hunter: But given, you know, the data that was presented at ASCO, we viewed that as very favorable, and I think an extension of those results to the end of the phase one trial would be, in fact, very favorable. Got it. Thank you. And just curious if, Uh, if there's a reason that, you know, in the initial data cut of the phase one data, there wasn't a correlation between PSA-50 response rate and CD46 expression. I'm curious if you have an explanation for that and also maybe how we should be thinking about how that data fits into the context of identifying patients with CD46 expression as a part of your development. Yeah, no, that The IHC assay that was used to assess CD46 expression in those patients may not be representative of what we would have seen had we been able to do the IHC with the targeted antibody itself because there are some differences that have been noted in IHC with YS5, the targeting antibody, and some of the commercially available reagents that work better on formalin-fixed tissue.

Speaker Change: But given.

Speaker Change: The data that was presented at <unk>, we view that as very favorable and I think an extension of those results to the end of the phase one trial. We would do is in fact very favorable.

Speaker Change: Got it thank you and just curious Ed.

Speaker Change: There's a reason.

Data cut of the phase one data.

Speaker Change: Wasn't a correlation between PSA response rate and CD 46 expression.

Speaker Change: Im curious if you have an explanation for that and also maybe how we should be thinking about how that data fits into the context.

Speaker Change: Identifying identifying patients with <unk> expression.

Speaker Change: Part of your development plan.

Speaker Change: Yes, no thats a very good point the IH C assay that was used to assess CD 46 expression in those patients.

Speaker Change: May not be representative of what we would have seen had we been able to do the IH C with the targeted antibody itself.

Speaker Change: Because there are some differences that have been noted NIH C with wyeth five targeting antibody.

Speaker Change: And some of the commercially available reagents that work better on formula and fixed tissue. One of the reasons. We're very excited about the pet biomarker is that we do use the same antibody. It sees the same epitope and we think that that will be a much more reliable indicator of how expression correlates with efficacy.

John Hunter: One of the reasons we're very excited about the PET biomarker is that it sees the same epitope, and we think that that will be a much more reliable indicator of how expression correlates with efficacy. Got it. Thank you so much. Thank you. I'm showing no further questions at this time. I'd like to turn the call back over to CEO Thane Weddick for any closing remarks. Yeah, thanks, everyone. We appreciate your participation in today's call and your continued interest in FibroGen. And we'd love for you guys to enjoy the rest of your day. Thank you. Thank you. Ladies and gentlemen, this does conclude today's conference. Thank you all. You may now disconnect. Have a great day!

Speaker Change: Got it thank you so much.

Speaker Change: Thank you I'm showing no further questions at this time I'd like to turn the call back over to CEO, Dan <unk> for any closing remarks.

Dan: Yes. Thanks, everyone. We appreciate your participation in today's call and your continued interest in <unk>.

Dan: And we'd love for you guys to enjoy the rest of your day. Thank you.

Speaker Change #100: Thank you ladies and gentlemen, this does conclude today's conference. Thank you all for participating you may now disconnect have a great day.