FibroGen Inc. Q2 2024 Earnings Call

Dave: The 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 statement, 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'd like to turn the call over to our CEO, Thane Wettig.

Can be found in Viper against filings with the SEC.

Speaker Change: <unk>, our most recent Form 10-K and Form 10-Q.

Speaker Change: Virgin does not undertake any obligation to update publicly any forward looking statements, whether as a result of new information future events or otherwise the press release reporting our financial results and business update and a webcast of today's conference call can be found in the investors section of fiber <unk> website at www dot fiber Gen dot com with that.

Speaker Change: I'd like to turn the call over to our CEO, saying what it.

Thane Wettig: Thanks, Dave. And good afternoon, everyone.

Speaker Change: Thanks, Dave and good afternoon, everyone and welcome to our second quarter 2024 earnings call.

Thane Wettig: And welcome to our second quarter 2024 earnings call. On today's call, I will focus our stakeholders on the updated go-forward strategy for the company and highlight the attractive opportunities that FibroGen has in front of it. Dr. Deyaa Adib, our Chief Medical Officer, will provide an overview of the prostate cancer landscape, discuss the development plan of our CD46-targeted antibody drug conjugate, FT-3246, and associated PET-46 imaging agent in metastatic castration-resistant prostate cancer, and articulate why we feel so strongly about recently released Phase I top-line results, and Juan Graham, our CFO, will review the financials after which we will open the call for your questions.

Speaker Change: On today's call I will focus our stakeholders on the updated go forward strategy for the company and highlights the attractive opportunities that Biogen has in front of it Dr.

Speaker Change: Dr. Dee <unk>, our Chief Medical Officer, who will provide an overview of the prostate cancer landscape discuss the development plan of our CD 46 targeted antibody drug conjugate FTE $32 46, and associated 46 imaging agent in metastatic castration resistant prostate cancer and articulate why we feel so.

Speaker Change: Strongly about recently released phase one topline results.

Speaker Change: And one Gram our CFO will review the financials after which we will open the call for your questions.

Thane Wettig: On slide 3, I would like to provide a recap of the recently announced late-stage PAM-REBL-MAP clinical trial results in pancreatic cancer. Last week, we reported top-line data from the PAM-Revlimab Experimental Arm in PAM-CAN's Precision Promise Phase 2-3 Adaptive Platform Trial, which compared treatment with PAM-Revlimab combined with gemcitabine plus nabpaclitaxel, The pan-rubbermap arm of the study did not meet the primary endpoint of overall survival as determined by the protocol pre-specified Bayesian statistical analysis.

Thane Wettig: We also announced top-line data from the FibroGen-sponsored Phase 3 LAPIS trial, which compared treatment with pamrevo-meth combined with gemcitabine plus nampapotaxil-4-folferanox to placebo combined with gem plus nampapotaxil-4-folferanox for the treatment of locally advanced unresectable pancreatic cancer. The study also did not meet the primary endpoint of overall

Thane Wettig: When FibroGen advanced Tamrivelmab into phase 3 development, we knew the challenges associated with a first-in-class mechanism targeted at three very difficult diseases, idiopathic pulmonary fibrosis, Duchenne muscular dystrophy, and pancreatic cancer, diseases with substantial unmet need and little advancement in patient outcomes over the past several years. Unfortunately, for patients, as well as other FibroGen stakeholders, Tamrivelmab will not be a solution that will enable patients to live longer and more productive lives.

Thane Wettig: Specific to pancreatic cancer, we were hopeful that panrevlimab would demonstrate a meaningful overall survival benefit, especially after we learned of the progression from stage 1 to stage 2 of the Precision Promise Adaptive Platform trial. However, this was simply not the result.

Thane Wettig: We would like to thank the patients and clinical trial investigators for their dedication and participation in both pancreatic cancer trials. Due to these results, the company is implementing a significant cost reduction plan, which unfortunately includes reducing headcount in the U.S. by approximately 75%. I would like to express my deepest gratitude to our FibroGen colleagues, who have dedicated so much of their time and energy to the prospect of bringing much-needed therapies to some of the most challenging and deadly diseases affecting humanity.

Thane Wettig: On slide four, I would like to highlight the exciting assets that FibroGen has. First is FG3246, a first-in-class potent antibody drug conjugate, or ADC, targeting CD46 for the treatment of metastatic, castration-resistant prostate cancer and potentially other solid tumors. This program also includes the development of an associated CD46-targeted PET imaging agent.

Thane Wettig: In April, we released compelling data from our FG-3246 Phase I monotherapy trial, and in June, additional compelling preliminary data from the dose escalation portion of the Phase I slash II investigator-sponsored study of FG-3246 in combination with enzalutamide in patients with MCRPC. The combination data will be presented at the 2024 ASCO Annual Meeting. Deyaea will provide more detail on these two Phase I studies later in the call. We anticipate two catalysts for FG3246 in 2025. Top line data from the Phase II portion of the combination trial in the first half of 2025 and the initiation of the Phase II monotherapy trial in the first quarter of 2025.

Thane Wettig: Roxy Juice Data is approved in over 40 countries, generates significant net revenue and positive cash flow, and provides FibroGen with material and growing economics through our partnerships with AstraZeneca and Estella's Pharma. Due to Strong Rock's two-step performance in China, we are raising our guidance for full year 2024. We now expect FibroGen's full-year net product revenue under U.S. GAAP to be between $135 and $150 million, up from $120 to $135 million, and four-year Roxaducet net sales in China of $320 to $350 million, up from our previous guidance of $300 to $340 million. Juan will cover our financials in more detail later on the call.

Gram: Up 300 $340 million, one will cover our financials in more detail later on the call.

Thane Wettig: We are also expecting an approval decision from the Chinese authorities in the second half of 2024 for chemotherapy-induced anemia, which, if approved, would represent meaningful revenue growth on top of the substantial revenue generated by ROX-DUSTAT for anemia associated with chronic kidney disease. Next, FibroGen has a number of partnering opportunities for our remaining pipeline. Earlier this year, we regained the rights to Roxidustat from AstraZeneca in the U.S. and ROW territories, excluding China and South Korea.

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

Next five or 10 has a number of partnering opportunities for our remaining pipeline.

Gram: Earlier this year, we regained the rights to <unk> from Astrazeneca in the U S. In <unk> territories, excluding China and South Korea.

Thane Wettig: This allows us the opportunity to potentially partner Roxidustat in certain indications with high-end needs, such as anemia in patients with lower-risk myelodysplastic syndrome. Based on the data presented at ASH in December of last year, which demonstrated a meaningful difference in transfusion independence between roxidustat and placebo in patients with anemia associated with lower risk MDS who entered the trial with a higher transfusion burden, we believe roxidustat is an excellent candidate for a focused phase three trial in lower risk MDS, a condition which represents a significant unmet need with a substantial commercial opportunity.

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

Speaker Change: Just on the data presented at Ash in December of last year, which demonstrated a meaningful difference in transfusion independence between <unk> and placebo in patients with anemia associated with lower risk Mds, who entered the trial with a higher transfusion burden. We believe <unk> is an excellent candidate for a focused phase III trial.

Speaker Change: And lower risk Mds, a condition, which represents a significant unmet need with a substantial commercial opportunity.

Thane Wettig: Second, we have made a difficult decision to stop internal development of the two immuno-oncology programs we licensed from HiFiBio in 2021. Given the organizational changes we announced last week, we simply don't have the resources to advance these programs as quickly as they deserve.

Speaker Change: Second we have made the difficult decision to stop internal development of the two immuno oncology programs, we licensed from <unk> bio in 2021 given.

Speaker Change: Given the organizational changes, we announced last week, we simply don't have the substrate to advance these programs as quickly as they deserve.

Thane Wettig: We continue to be very excited about the potential of these programs and believe there are partnering opportunities for both of these assets. We have made important advancements to de-risk these programs, including optimizing the affinity of and receiving IND clearance for FG3165, our antigelectin-9 monoclonal antibody, enabling the product to be phase one ready. We have also made significant progress optimizing the activity of FG3175, our anti-CCR8 monoclonal antibody, advancing it to a point where we believe it has best-in-class potential.

Thane Wettig: As we announced in June, we have also signed a clinical trial supply agreement with Regeneron to study both of these assets in combination with Leptio. We will begin partnering discussions for both FG3165 and FG3175 with interested parties in the near future. Lastly, our strong cash position. We finished the second quarter with approximately $147.1 million in cash, cash equivalents, and accounts receivable. We expect our balance sheet to be sufficient to fund our operating plans into 2026.

Thane Wettig: In summary, we believe that we have a strong foundation to drive significant shareholder value creation today and into the future. I will now turn the call over to Deyaa Adib, our Chief Medical Officer, to discuss prostate cancer, NFG 3246.

Deyaa Adib: Moving on to slide six, I would like to provide a brief overview of the prostate cancer landscape and the high unmet need in late stage disease. Prostate cancer is the most common cancer in men in the United States, who currently have a 1 in 8 lifetime risk of developing the disease. There are approximately 290,000 new diagnoses of prostate cancer each year in the U.S., with 65,000 diagnoses where the cancer has metastasized, become castrate-resistant, and is drug-treatable.

Deyaa Adib: The five-year survival rate in these late-stage patients is approximately 30%. There is a significant unmet medical need for therapies that extend survival in these late-stage patients that have progressed on androgen receptor signaling inhibitors, or ARSIs, and chemotherapy. Turning to slide seven.

Deyaa Adib: FG3246 is a potential first-in-class ADC targeting CD46, in development for metastatic castration-resistant prostate cancer, with potential future development in colorectal cancer and other tumors. FG3246 binds to a cell receptor target that internalizes upon antibody binding and is present in approximately 50-70% of prostate tumors. But it demonstrates very limited expression in most normal tissues, making it an ideal ADC target candidate.

Deyaa Adib: FG3246 is comprised of an anti-CD46 antibody, YS5, linked to the antimyotic agent MMAE, which is a clinically validated and FDA-approved ADC payload. Associated PET Imaging Agents, PET-46, utilizes the same targeting antibody as FG3246 and is under clinical development at UCSF. It is constituted of the YS5 antibody coupled to the radionuclide zir On slide 8, we highlight the importance of the companion PET imaging agent, PET-46, to the development pathway of FG32-46.

Deyaa Adib: We believe that utilizing PEP-46 as a patient selection biomarker will allow FG32-46 to achieve a differentiated clinical profile in prostate cancer treatment paradigms. We believe that PET-46 will be superior to CD46-IHC, due to the fact that PET-46 is applicable to the entire MCRPC population, while IHC is reserved for patients who have biopsy-accessible disease. This will allow the company to better enrich the patient population studied throughout the clinical development program.

Deyaa Adib: Now, let's go into the top-line results from the monotherapy phase 1 study in metastatic CRPC, slide 9. In phase one, those escalation components of the trial, those levels of FG3246 were administered over 21 days. In the dose expansion arm of the trial, patients were treated at 2.7 mg per kg, adjusted body weight, capping 200 kg, until disease progression or the occurrence of an unacceptable toxicity, for example, a DLT. The endpoints were safety, tolerability, and anti-tumor activity, as measured by the decline of prosthetic-specific antigen from baseline, objective tumor response rate in patients who have measurable disease, and radiographic progression-free survival using the Prostate Cancer Working Group criteria for tumor response assessment.

Deyaa Adib: The completed Phase 1 trial included a total of 56 metastatic castration-resistant prostate cancer patients who were biomarker unselected and had received a median of five prior lines of therapy before they were administered FG3246. In the efficacy population, we observed a median radiographic progression-free survival of 8.7%. For Resist Evaluable Patients, 20% met the criteria of a partial response or a tumor reduction in size of at least 30%, with a median duration of response of 7.5. PSA reductions of more than 50% were observed in 36% of patients.

Speaker Change: Median duration of response of seven five months.

Speaker Change: <unk> reductions of more than 50% or observed at 36% of patients.

Deyaa Adib: FG-3246 demonstrated an acceptable safety profile, with adverse events consistent with those observed in other antibody drug conjugate therapies that have an MMAE payload. We look forward to publishing the totality of the Phase I data in a manuscript in the upcoming months, as we plan the advancement of the program further in the clinic. Moving to slide 10.

Speaker Change: At June 32, 46 demonstrated an acceptable safety profile.

With adverse events consistent with those observed in other antibody drug conjugate therapies.

Speaker Change: That havent MMA payloads, we look forward to publishing the totality of the phase one data in a manuscript in the upcoming months as we plan the advancement of the program further in the clinic.

Speaker Change: Moving to slide 10.

Deyaa Adib: There is also a combination study with emzolotamide that is currently being run at UCSF as a sponsor trial, as an investigator sponsor trial. We announced positive interim results from this dose escalation component of the study, which is a phase 1b2 trial of FG3246 in combination with enzalutamide in patients with MCRPC at the ASCO 2024 annual meeting. The presentation included data from 17 biomarker-unselected patients in the dose escalation component of the study.

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

Speaker Change: That is currently being run at UCSF as a sponsor trial.

Speaker Change: Investigator sponsor trial, we announced positive interim results from this dose escalation component of the study.

Deyaa Adib: Over 70% of patients in the study received at least two prior ARS tests, which included prior in the Lutheran. The primary endpoint was determined, determination of the Maximally Tolerable Dose, or MTD, for FG3246 in combination with Enzalutamol. The entity was established at 2.1 milligrams per kg adjusted body weight with primary GCSF prophylaxis in combination with enzalutamide at the prescription dose of 160 milligrams per day. The combination treatment demonstrated an encouraging preliminary result, showing an estimate of radiographic PFS of 10.2. With PSA declining, observed in 71%, or 12 out of 17, a valuable patient.

Speaker Change: Which is a phase <unk> trial of FG $32 46 in combination with <unk> in patients with MCR accuracy at the ESMO 2024 annual meeting.

Speaker Change: The presentation included data from 17 biomarker unselected patients in the dose escalation component of the study.

Speaker Change: Over 70% of patients in the study received at least two prior aortic side.

Speaker Change: Which included prior and so a lot of lines.

Speaker Change: The primary endpoint was determined.

Speaker Change: The termination of the maximally tolerated dose or MTV.

Speaker Change: Four F G $32 46 in combination with Xeloda alone.

Speaker Change: MTV was established at $2, one milligram per kg adjusted body weight with primary G. CSF prophylaxis in combination with <unk> at the prescription dose of one 160 milligram per day.

Speaker Change: The combination treatment.

Speaker Change: Demonstrated an encouraging preliminary results showing an estimate of that geographic PFS of $10 two months with BSA declining.

Served in 71% or 12 out of 17 Evaluable patients.

Thane Wettig: We're excited to announce that we expect top-line results from the Phase II component of this investigator-initiated study in the first half of 2025, and these results will also include additional data on patients screened with PEP-46 during the Phase II component, enrollment period. On slide 11, I would like to discuss a few endpoints in metastatic CR. We believe that radiographic PFS is a clinically meaningful endpoint versus other surrogate signals such as PSA-50 and objective response.

Speaker Change: We're excited to announce that we expect topline results from the phase II component of this investigator initiated study in first half of 2025 and these results will also include additional data on patients screened with pet 46 during the phase two components.

Speaker Change: Enrollment periods.

Speaker Change: On slide 11.

Speaker Change: I would like to discuss a few endpoints in metastatic CRP C.

Speaker Change: We believe that sort of geographic PFS is a clinically meaningful endpoint.

Speaker Change: Versus other surrogate signals such as PSA 50, and objective response rate.

Thane Wettig: Other earlier stage data in the same space have only shown results from PSA-30 and PSA-50 as signals of clinical activity in a very limited number of patients but have not yet shown survival, which constitutes the clinically meaningful endpoint in metastatic castration-resistant processes. For FG-3246, we believe... a radiographic PFS of 8.7 months as monotherapy in a heavily pretreated, unselected population and a radiographic PFS of 10.2 months in combination with enzalutamide in an earlier treatment line. Treatment with pre-treated ARSI patients is very compelling versus existing standards of care in the MCRPC setting. Moving to slide 12.

Speaker Change: Other earlier stage data in the same space has only shown results from PSA <unk> and PSA 50 are signals of clinical activity in a very limited number of patients.

Speaker Change: But have not yet shown survival data, which constitutes the clinically meaningful endpoints in metastatic castration resistant prostate cancer.

Speaker Change: For FG three to 46, we believe.

Speaker Change: Ara geographic PFS of eight seven months as monotherapy in heavily pre treated unselected population.

Speaker Change: And the radiographic PFS of $10 two months in combination with <unk> in an earlier treatment line.

Speaker Change: With phase III LSI.

Speaker Change: <unk> patients is very compelling.

Speaker Change: Versus existing standards of care in the MCR P C.

Speaker Change: Moving to slide 12.

Deyaa Adib: We highlight all the recent and ongoing studies for FG3246. We are expecting to see more data generated for the PET46 biomarker in prostate cancer, which is in progress at UCSF this year.

Speaker Change: We highlight all the recent and ongoing studies for <unk> 32, 46, we are expecting to see a more data generated 40.

Speaker Change: 46 biomarker in prostate cancer.

Speaker Change: That is in progress at UCSF this year.

Deyaa Adib: As we have articulated, the goal is to develop a companion PET imaging agent to select those patients with ICD-46 expression who are most likely to benefit from the treatment with FG-3248. PET-46 will be part of a phase 2 dose optimization monotherapy study sponsored by FibroGen and could potentially enhance screening, patient selection, and enrichment, ensuring proper selection of patients for the targeted therapy to receive a clinically meaningful benefit.

Speaker Change: As we have articulated the goal is to develop a companion pet imaging agent to select those patients with ICD 46 expression, who are most likely to benefit from the treatment with FG three to 46.

Speaker Change: But 46 will be part of a phase two dose optimization monotherapy studies sponsored by five Virginia.

Speaker Change: And could potentially enhanced screening patient selection and enrichment ensuring proper selection of patients.

Speaker Change: For the targeted therapy to receive.

Speaker Change: A clinically meaningful benefits.

Speaker Change: On slide 13.

Thane Wettig: We highlight the upcoming catalysts for the FG3246 program. We are meeting with the FDA this quarter. We expect to file FibroGens IND for FG3246 this quarter, as well as file the FibroGens IND for PET46 next year. We anticipate the initiation of a phase two dose optimization study in MCR-PC in the first quarter of 2025 and expect timeline results from the phase two portion of the combination study being run at UCSF in combination with enzalutamide in the first half of 2025.

Speaker Change: We highlight the upcoming catalysts for F. G 30 to 46 program.

Speaker Change: We are meeting with the FDA this quarter.

Speaker Change: We expect to find fiber <unk> for F. G 30 to 46 this quarter as well as finding the fiber Jens <unk> 46 next quarter.

Speaker Change: We anticipate the initiation of a phase two dose optimization study in MCR PC in the first quarter of 2025 and expect complying results from the phase II portion of the combination study being run at UCSF in combination with <unk> in first half of 2025.

Thane Wettig: Finally, moving to slide 14, we want to summarize the unique opportunity that FG3246 represents. The molecule represents a novel mechanism of action and a first-in-class opportunity, bearing an antibody against a novel target with a validated chemotherapy failure. FG3246 may offer a treatment beyond prostate cancer with potential applications in multiple treatment lines of CRPC in combination with enzalutamide and other solid tumors such as colorectal. FG3246 could potentially represent a paradigm shift in oncology, offering not only a novel mechanism of action but also promising efficacy, safety, and potential across various cancers. We look forward to updating you on LG3246 as studies progress. I will now turn the call back to Thane to discuss RuxadaStats. Okay? Thane?

Speaker Change: Finally, moving to slide 14.

Speaker Change: To summarize the unique opportunity that FG three to 46 represents.

Speaker Change: The molecule represents an <unk> mechanism of action and it first in class opportunity.

Speaker Change: Bearing an antibody against the novel targets with a validated chemotherapy payloads.

Speaker Change: F. G $32 46 may offer a treatment beyond prostate cancer with potential applications in multiple treatment lines of M. A C. RPC in combination with Enzo termite and other solid tumors such as colorectal cancer.

Speaker Change: <unk> started 246 could potentially represent a paradigm shift in oncology offering not only a novel mechanism of action, but also promising efficacy safety and potential across various cancer types.

Speaker Change: We look forward to updating you on MG 30 to 46 as studies progressed.

Speaker Change: I will now turn the call back to <unk> to discuss the Baxalta stake sale.

Thane Wettig: Thank you, Deyaa. Moving now to slide 16, ROX-DUCET for anemia of chronic kidney disease continues to perform extremely well in China. Second quarter total ROX-DUCET net sales in China by FibroGen and the distribution entity jointly owned by FibroGen and AstraZeneca totaled $92.3 million, compared to $76.4 million in the second quarter of 2023, an increase of 21%. This growth was driven by an increase in volume of 33%.

Speaker Change: Thank you Dale moving now to slide 16 roster step for anemia of chronic kidney disease continues to perform extremely well in China second quarter total <unk> net sales in China by five version and the distribution entity jointly owned by by Virginia, and Astrazeneca totaled $92.

Speaker Change: $3 million compared to $76 $4 million in a second.

Speaker Change: Quarter of 2023, an increase of 21%. This growth was driven by an increase in volume of 33%.

Thane Wettig: FibroGen's portion of Roxas-Ducette Net Product Revenue in China was $49.6 million for the second quarter on a U.S. GAAP basis compared to $23.9 million in the second quarter of 2023, an increase of 108%. Moving to slide 17, Rox2Set continues its category leadership and brand value share in China, maintaining a 46% share in the most recent three-month period ending in May of 2024. The potential addition of the chemotherapy-induced anemia indication would provide an important new treatment alternative for patients with chemotherapy-induced anemia and would be a meaningful addition to the ROX-2STAT business in China.

Barbara: Barbara just portion of <unk> net product revenue in China was $49 $6 million for the second quarter on a U S GAAP basis compared to $23 9 million in the second quarter of 2023, an increase of 108%.

Speaker Change: Moving to slide 17 rocks to set continues its category leadership and brand value share in China, maintaining a 46% share in the most recent three months period ending in May of 2020 for the.

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

Thane Wettig: Given that there have been several generic applications filed and two applications approved in China, I would like to reiterate the dynamics of the generic market in China and the exclusivity of rocks-to-juice tabs. The impact of a generic approval and launch in China is meaningfully different from the U.S. market. 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.

Speaker Change: Given that there have been several generic application smile and two applications approved in China.

Speaker Change: I'd like to reiterate the dynamics of the generic market in China, and the exclusivity of <unk> staff.

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

Speaker Change: Generic player space 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.

Thane Wettig: Originator products do not experience a meaningful deterioration in revenue until they are subjected to volume-based purchasing, which only occurs after at least four generic products are approved and the government includes the originator in the VBP process. 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 expiration of our Composition of Matter Patents in June of 2024, we do not expect meaningful deterioration of the ROC's DUSTEP business in the near term.

Speaker Change: Originator products did not experience a meaningful deterioration in revenue until they are subjected to volume based purchasing which only occurs after at least or generic products are approved and the government includes the originator and the BBC process.

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 of 2024, we do not expect meaningful deterioration of the rocks just that business in the near term.

Thane Wettig: In addition to the continued outstanding performance of RoxaDucet in China, RoxaDucet penetration in Europe continues to increase, showing quarter-over-quarter growth. We expect this growth to continue, given the fact that ROC's reduced debt is reimbursed in all EU5 countries and is the only FPHI indicated in the EU for the treatment of anemia of CKD in both non-dialysis and dialysis patients. Importantly, Procedure Stat has exclusivity into 2036 in the EU, positioning it for continuous growth and hip market leadership over the next decade plus.

Speaker Change: In addition to the continued outstanding performance of rocks that you sit in China <unk> penetration in Europe continues to increase showing quarter over quarter growth.

Speaker Change: We expect this growth to continue given the fact that <unk> is reimbursement all EU five countries and is the only <unk> indicated in the EU for the treatment of anemia in <unk> in both non dialysis and dialysis patients importantly, <unk> has exclusivity into 2036 in the EU.

Speaker Change: Positioning that to continuous growth in hip market leadership over the next decade plus.

Thane Wettig: Moving to slide 18, earlier in the year, we announced that AstraZeneca returned all U.S. and R.O.W. Roxas-Doucet rights to China, with the exception of South Korea. FibroGen's collaboration agreement with AZ for Roxas-Doucet in China remains firmly in place. Regaining the rights to Roxas-Dustet in the U.S. allows us to pursue Roxas-Dustet development opportunities with potential partners and indications such as anemia associated with lower-risk myelodysplastic syndromes. I will now turn the call over to Juan to discuss the company's financials. Okay, Juan?

Speaker Change: Moving to slide 18 earlier in the year, we announced that Astrazeneca returned to all U S and our OWS rocks Doucet rights to China with the exception of South Korea, <unk> collaboration agreement with AC <unk> set in China remains firmly in place we're.

Speaker Change: We're getting the right structure to sit in the U S allows us to pursue <unk> development opportunities with potential partners in indications such as anemia associated with lower risk Myelodysplastic syndromes.

Ward: I will now turn the call over to ward to discuss the Companys financials one.

Ward: Thank you bank.

Juan: Firstly, I would like to take a few moments to thank the entire FibroGen team for their hard work and dedication over the years. The organization has courageously focused on developing therapies for very difficult diseases affecting humanity. And while our objective was not achieved, I expect our learnings to provide valuable information for the development of new therapies in the future to provide options for patients affected with pancreatic cancer.

Ward: Firstly I would like to take a few moments to thank the entire fiber gem team for their hard work and dedication over the years the.

Ward: The organization has courageously focused on developing therapies in very difficult diseases affect things Humana.

Speaker Change: And while our objective was not achieved.

Ward: Our learnings to provide valuable information for developing new therapies in the future to provide options for patients affected with pancreatic cancer.

Juan: I will focus my remarks with a revenue summary for the second quarter of 2024, subsequently providing financial performance details on our China business for the quarter, and finally, I will wrap up with operating expense results and our cash out. For the second quarter of 2024, total revenue was $50.6 million compared to $44.3 million for the same period in 2023, an increase of 14% year-over-year.

Speaker Change: I will focus my remarks, with our revenue summary for the second quarter of 2024 subsequently, providing financial performance details from our China business for the quarter and finally, I will wrap up with operating expense results and our cash outlook.

Ward: For the second quarter of 2024 total revenue was $50 6 million compared to $44 3 million for the same period in 2023 and.

Speaker Change: An increase of 14% year over year.

Juan: We recorded $49.6 million of net product revenue for Roxa Dustet sales in China, compared to $23.9 million in the second quarter of 2023, representing an increase of about 108% year-on-year. The drivers for this increase were 1. Volume growth of 33% versus last year, and 2. Changes in assumptions of our future revenue expectations led to a deferred revenue release of $18 million. However, Ruck's reduced performance in China continues to deliver strong results, supporting patients with CKD.

Speaker Change: We recorded $49 $6 million net product revenue for Rockford, you start sales in China, compared with $23 $9 million in second quarter of 2023.

Speaker Change: Something I'm, increasing 108% year over year.

Ward: Drivers for this increase were one volume growth of 33% versus last year.

Ward: And to changes in assumptions of our future revenue expectations, leading towards the FERC revenue <unk> of $18 million.

Speaker Change: The new store performance in China continues to deliver strong results supporting patients with Ckc.

Juan: In Q2 2024, we recorded $0.3 million in development revenue compared to $5.2 million during the second quarter of 2023. As mentioned last quarter, after the termination of the AstraZeneca-U.S. rest of world agreement, we expect quarterly development revenue to be below half a million dollars for the remainder of. In Q2 2024, we recorded $0.7 million of direct product revenue compared to $14.3 million during the second quarter of 2023 The performance of Roxodusta in the Astellas Territories has continuously been weaker than expected.

Speaker Change: In Q2, 2024, we recorded zero point $3 million in development revenue compared to $5 $2 million through the second quarter of 2023.

Speaker Change: As mentioned last quarter after the termination of the Astrazeneca U S rest of World agreement.

Speaker Change: We expect quarterly development revenue to be below half a million dollars for the remainder of the year.

Speaker Change: In Q2, 2024, we recorded <unk> $7 million of drug product revenue compared to $14 $3 million during the second quarter of 2023.

Speaker Change: The performance of Rockford knew starting the Astellas territories has continuously been weaker than expected.

Juan: We continue to assess the impact of future forecasted net sales performance and associated royalties to FibroGen, which we anticipate will lower the future projected cash inflows related to Estella Sterling. I will now move to provide further detail on our financial performance chart. Total ROXADUCE.NET sales from the Joint Distribution Entity, or JDE, owned by AstraZeneca and FibroGen and direct-to-distributor sales from FibroGen were $92.3 million this quarter, compared to $76.4 million in the second quarter of 2023, an increase of 21% year-over-year. This growth has enabled us to achieve and maintain a brand value share of 46% in the category in

Speaker Change: We continue to assess the impact of future forecasted net sales performance and associated royalties to fiber.

Speaker Change: Which we anticipate will lower the future projected cash inflows related to our service territories.

Speaker Change: I will now move to provide further detail on our financial performance.

Juan: From total Roxadusta net sales in China, FibroGen's net transfer price from sales to the JDE was $28 million this quarter, compared to $23.8 million in the second quarter of 2023, an increase of 18% year over year. Net Trend Enterprise is the best reflection of FibroGen's portion of the cash received from Roxadustat in China. During this quarter, as I stated earlier, we also released $18 million from the FERC revenue due primarily to changes in forward-looking expectations for Roxabusta in China.

Speaker Change: Total works with you starting net sales from the joint distribution entity or JV owned by Astrazeneca and fiber, Jim and the rest of the distributor sales from fiber and Jim was $92 $3 million this quarter compared to $76 $4 million in the second quarter of 2023.

Speaker Change: An increase of 21% year over year.

Speaker Change: This growth has enabled us to achieve and maintain a brand bellevue share of 46% in the category in China.

Speaker Change: From a total rux when do you start net sales in China fiber jumps in that transfer price from sales to the JV. He was $28 million this quarter compared to $23 $8 million in the second quarter of 2023 and.

Speaker Change: <unk> increased 18% year over year.

Speaker Change: Net pricing the best reflection of fiber jumps portion of the cash received from Brooks of Destocking in China.

Speaker Change: During this quarter as I started as I stated earlier.

Speaker Change: We also released $18 million from the FERC revenue due primarily to changes in forward looking expectations for <unk> B study in China.

Juan: As a result, FibroGen recorded $46 million in net revenue for the quarter from Roxy Dustedt sales to the JDE and $3.6 million of direct-to-distributor sales from FibroGen China, totaling $49.6 million on a U.S. GAAP basis. This revenue growth highlights the continuous robustness in execution and physician and patient adoption of Roxodustat in China. Portfolio Year 2024. For your models, we are racing our forecast for FibroGen China net product revenue to be between $135 to $150 million in the US gap base, which assumes a forecast of ROXEDU stat debt sales in China should range from $320 to $350 million. Now moving down the Incas.

Speaker Change: As a result fiber Jim recorded $46 million in net revenue for the quarter or <unk> sales grew to J D E F $3 $6 million of direct to distributor sales for fiber didn't try.

Speaker Change: Totaling $49 6 million on a U S GAAP basis.

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

Speaker Change: For full year 2024 for your models, we are raising our forecast for fibers in China on net product revenue to be between $135 million to $150 million in the U S GAAP basis.

Speaker Change: Which assumes a forecast of Brookside, you said that sales in China, a share range from $320 million to $350 million.

Speaker Change: Now moving down the income statement.

Juan: Operating costs and expenses for the second quarter of 2024 were $61.6 million compared to $132.4 million for the second quarter of 2023, a decrease of $70.8 million, or 53% year-over-year. Operating expenses for the quarter came in below our guidance range of $70 to $80 million, a reflection of our continuous drive on disciplined spend showcased in our second quarter results. R&D expenses for the second quarter of 2024 were $34.1 million compared to $95.5 million in the second quarter of 2023, a decrease of 64% or $61.4 million year-over-year, primarily reflecting reductions in pre-merlema clinical trial spend, R&D infrastructure, and one-time Fortis acquisition expenses. So, for $34.1 million of R&D expenses, approximately 58% was related to Pembroke-LaMass 18% to support our immuno-oncology pipeline assets, with the remaining 5% directed towards RuxaDusta development activities.

Speaker Change: Operating costs and expenses for the second quarter of 2024 were $61 $6 million compared to $132 $4 million for the second quarter of 2023.

Speaker Change: Decrease of $78 million or 53% year over year.

Speaker Change: Operating expenses for the quarter came in below our guidance range of $70 million to $80 million a reflection of our continuous drive disciplined spend showcased in our second quarter results.

Speaker Change: R&D expenses for the second quarter of 2024, or $34 $1 million compared to $95 $5 billion in the second quarter of 2023, a decrease of 64% or $61 $4 million year over year.

Speaker Change: Primarily reflecting reductions in carbon clinical trial spend R&D infrastructure and onetime <unk> acquisition expenses.

Speaker Change: Of our $34 $1 million of R&D expenses, approximately 58% was related to farmer of about 18% directed to F. G $32 46.

Speaker Change: 18% to support our immuno oncology pipeline assets with the remaining 5% directed towards trucks and do stuff development activities. We expect our per member Mab on immuno oncology R&D expenses to decline significantly in the second half of the year.

Juan: We expect our primordial MAP and immune oncology R&D expenses to decline significantly in the second half of the year. FD&A expenses for the second quarter of 2024 were $22.3 million compared to $31.2 million in the second quarter of 2023. A decrease of 29% or $8.9 million year-over-year, primarily driven by the company's cost reduction efforts resulting in a leaner SG&A infrastructure. Finally, cost of goods sold for the second quarter of 2024 was $5.2 million compared to $5.7 million for the second quarter.

Speaker Change: SG&A expenses for the second quarter of 2024 were $22 3 million compared to $31 $2 million in the second quarter of 2023.

Speaker Change: Decrease of 29% or $8 $9 million year over year.

Speaker Change: Primarily driven by the company's cost reduction efforts, resulting in a leaner SG&A infrastructure.

Speaker Change: Finally cost of goods sold for the second quarter of 2024 was $5 2 million compared to $5 $7 million for the second quarter of 2023.

Juan: During the second quarter of 2024, we recorded a net loss of $15.5 million, or $0.16 net loss for both basic and diluted share, as compared to a net loss of $87.7 million, or $0.90 for basic and diluted share for the second quarter of 2024. Given the recent negative pembrokelimab outcome, we are winding down any remaining obligations related to pembrokelimab and RNA-i We have also announced a reduction in our U.S. workforce of approximately 75%.

Speaker Change: During the second quarter of 2024, we recorded a net loss of $16 5 million or <unk> 16.

Speaker Change: Net loss for both basic and diluted share as compared to a net loss of $87 $7 million of maintenance per basic and diluted share for the second quarter of 2023.

Speaker Change: Given the recent negative from rubber with my of outcome. We are winding down any remaining obligations related to perm revenue amount and our immuno oncology assets during the second half of 'twenty 'twenty four.

Speaker Change: We have also announced a reduction in our U S workforce of approximately 75%.

Juan: With this backdrop, and excluding any restructuring charges in the 3rd or 4th quarter, we expect our total operating expenses, including costs to get sold in the 3rd and 4th quarters, to be between $45 million and $55 million per quarter, with the third quarter estimated to be at the higher end, and the fourth quarter estimated to be at the lower end.

Speaker Change: With this backdrop and excluding any restructuring charges in the third or fourth quarter. We expect our total operating expenses, including cost of goods sold in the third and fourth quarter to be between $45 million and $55 million per quarter.

Speaker Change: With the third quarter estimated to be at the higher end in the fourth quarter estimated to be at the lower end of this rich.

Juan: Now shifting towards cash. As of June 30th, we reported $147.1 million in cash, cash equivalents, and a cleanse receivable. It is important to spend a few moments highlighting the changes in our cash balance. Our cash burn in the second quarter reflects a true-up payment to Astellas of $35.3 million. We expect any future trip payments to be significantly lower moving forward as Astellas has reduced their future orders of Ruxidustat to reflect a slower-than-anticipated launch in their territory.

Speaker Change: Now shifting towards cash.

Speaker Change: As of June 30, we reported 147 $1 billion in cash cash equivalents and our receivables.

Juan: Additionally, we also had a one-time inventory settlement payment of $11.5 million to AstraZeneca in the quarter due to the termination of our U.S. rest-of-world agreement. Excluding these cash outflows, our net operating cash burn was $20.8 million in the second quarter. We expect our second half 2024 quarterly net operating cash burn to be lower than what we experienced in the second quarter. We believe that the focus on cost reduction and cash maximization initiatives will enable us to continue to pursue our strategic direction.

Speaker Change: It is important to spend a few moments highlighting the changes in our cash balance our cash burn in the second quarter reflects a true up payment to astellas kept $35 $3 million, we expect any future payments to be significantly lower moving forward as astellas has reduced their future orders of Brexit new stuff to refer.

Speaker Change: The slower than anticipated launch in their territories.

Speaker Change: Additionally, we also had a onetime inventory settlement payment of $11 $5 million to astrazeneca in the quarter due to the termination of our U S rest of world the Green.

Speaker Change: Excluding these cash outflows, our net operating cash burn was $28 million in the second quarter.

Speaker Change: We expect our second half 2020 for quarterly net operating cash burn to be lower than what we experienced in the second quarter.

Speaker Change: We believe that the focus towards cost reduction and cash maximization initiatives will enable us to continue to pursue our strategic direction.

Juan: Finally, and as we have continuously communicated, we expect our cash, cash equivalents, and accounts receivable to fund our operating plans into 2026. Thank you, and now I will turn the call back over to... Thank you, Juan.

Speaker Change: Finally, and as we have continually communicated we expect our cash cash equivalents and accounts receivable to fund our operating plan into 2026.

Speaker Change: And now I will turn the call back over to Vic.

Thane Wettig: Thank you, Juan. In closing, we remain excited about the company's prospects and the potential value they provide to stakeholders. Roxadustat continues to perform very well in China, where we expect an approval decision for our SNDA for the chemotherapy-induced anemia indication in the second half of this year. And our partner, Estellas, continues with the commercialization of Roxadustat in Europe, Japan, and other markets.

Vic: Thank you on in closing we remain excited about the company's prospects and the potential value they provide to stakeholders.

Speaker Change: <unk> continues to perform very well in China, where we expect an approval decision of our S. NDA for the chemotherapy induced anemia indication in the second half of this year and our partner ourselves continues with the commercialization of <unk> in Europe, Japan and other markets.

Thane Wettig: Additionally, given that we regained rights for Roxadustat for USROW territories from AstraZeneca, we are actively exploring potential partnered opportunities in anemia in patients with lower-risk MDS. With regard to FG-3246 and PEP-46, we recently reported compelling top-line data from the Phase I monotherapy study of FT-3246 in metastatic castration-resistant prostate cancer, and we'll publish the totality We've also presented compelling preliminary top-line data from the Dose Escalation Phase 1b study of FG3246 in combination with Enzalutamide and MCRPC at the 2024 ASCO Annual Meeting in June.

Speaker Change: Additionally, given that we regained rights for <unk> for U S. R. W. Territories from Astrazeneca, we are actively exploring potential partnering opportunities and anemia in patients with lower risk Mds.

Speaker Change: With regards to FG $32 46, and <unk> 46, we recently reported compelling top line data from the phase one monotherapy study of FG three to 46 in metastatic castration resistant prostate cancer and we'll publish the totality of the phase one data in an upcoming manuscript with.

Speaker Change: We have also presented compelling preliminary topline data from the dose escalation phase <unk> study of FG three to 46 in combination with <unk> and <unk>.

Speaker Change: <unk> at the 2020 for <unk> annual meeting in June.

Thane Wettig: We anticipate initiating our Phase 2 Monotherapy Dose Optimization Study of FG3246 in MCRPC in the first quarter of 2025, and we anticipate top-line results from the Phase 2 portion of the Combination Study in the first half of 2025. As stated earlier in the call, we will initiate partnership discussions for our two early-stage immuno-oncology assets, FG3165 and FG3175, with the aim of ensuring their continued development and providing FibroGen with potential access to non-diluted capital.

Speaker Change: We anticipate initiation of our phase two monotherapy dose optimization study of FG $3 46, and <unk> in the first quarter of 2025, and we anticipate top line results from the phase II portion of the combination study in the first half of 2025.

Speaker Change: As we stated earlier in the call we will initiate partnership discussions for our two early stage immuno oncology assets at June 31, 65, and <unk> 31, 75 with the aim of ensuring their continued development and providing <unk> with potential access to non dilutive capital.

Thane Wettig: Finally, we have a strong balance sheet and expect our current cash position, as Juan said, to fund operations into 2026. In summary, we have made some very difficult but necessary decisions based on the outcomes of our two late-stage PemRevlimab trials in pancreatic cancer. We believe these decisions best position FibroGen to successfully execute against our updated strategic priorities as we strive to attain a valuation that we believe is more reflective of our current and future Rox2Sat revenue streams, first-in-class EDC, and companion PET imaging agent in our strong balance sheet. I would like to thank all of the employees at FibroGen for their continued hard work and perseverance over the last few months. I would now like to turn the call over to the operators for Q&A.

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

Speaker Change: In summary, we have made some very difficult, but necessary decisions based upon the outcomes of our two late stage <unk> trials in pancreatic cancer. We believe these decisions best position <unk> to successfully execute against our updated strategic priorities as we strive to obtain a valuation that we believe is more reflective.

Speaker Change: Of our current and future rocks through set revenue streams first in class ADC and companion pet imaging agent and our strong balance sheet.

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

Operator: We will now begin the question and answer session. To ask a question, you may press star, then one on your touch-tone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been answered and you would like to withdraw your question, please press star then 2. At this time, we will pause momentarily to assemble our roster. The first question comes from Andy Shea with William Blair. Please go ahead.

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

Speaker Change: Thank you.

Speaker Change: We will now begin the question and answer session to ask a question you May Press Star then one on your Touchtone phone if youre using a speakerphone. Please pick up your handset before pressing the keys.

Speaker Change: If at any time. Your question has been addressed and you like to withdraw your question. Please press Star then two.

Speaker Change: At this time, we will pause momentarily to assemble our roster.

Speaker Change: The first question comes from Andy Shay with William Blair. Please go ahead.

Speaker Change: Hi, This is Don Greenwood on for Andy Shay, Thank you for taking our questions.

Speaker Change: Given our singular focus on ft $32 46, now do you have any plans on accelerating its development just to maximize the assets value for shareholders. In parallel you have a very robust China business based on the strength of <unk> clinical profile could you comment on the liquidity of cash generated in China in other words, how do you as a U S entity access to cash to <unk>.

Speaker Change: <unk> revenue thank you.

Thane Wettig: Hey Dalton, this is Thane. Thanks for your questions. I'll touch on the 3246 question, and then I'll ask Juan to touch on the question about liquidity of cash from our China operations. And obviously, Chris Chung is here as well to compliment Juan if needed. As it relates to 3246, you know, it has always been a priority asset for us since we acquired it from Fortis in May of last year. We just didn't highlight it to the extent that we highlighted PAM RebelMap just because of the proximity of the catalyst for PAM RebelMap at that time.

Speaker Change: Hey, Don this sustained thanks for your questions I'll touch on the $32 46 questions and then I'll ask one to touch on the question about liquidity of cash from our China operations, and obviously, Chris John This year as well.

Speaker Change: Uh huh.

Speaker Change: To complement one abated.

Speaker Change: As it relates to $32 46.

Speaker Change: <unk>.

Speaker Change: It has always been a priority asset for us since we acquired it from Fortis in May of last year.

Speaker Change: Didn't highlighted to the extent that we highlighted rebel that just because of the proximity of the catalyst program rebel map.

Thane Wettig: And so it has been and will continue to be an asset that we will try to prosecute with speed because that's the name of the game in our business, quality and speed. We have an important interaction coming up with the FDA this quarter, which will help inform the design of the Phase 2 trial. And we would expect them to be able to plan on the initiation of the Phase 2 program after that point in time. So yeah, we are pursuing it as quickly as we can. You know,

Speaker Change: From that time, and so it has been and will continue to be an asset that we will try that to prosecute.

Speaker Change: With speed because thats the name of the game and our business is quality and speed.

Speaker Change: We have an important an important interaction coming up with the FDA this quarter, which will help inform the design of the phase II trial, and we would expect them to be able to plan on the initiation of the phase III program.

Speaker Change: After that point in time, so yes, we are prosecuting it as as quickly as we can.

Juan: With regard to your second question, this is one. With regard to cash generation in China, over the course of the last year or so, we have been repatriating cash from China based on a facility that we had set up as registered debt with our Chinese operations. We will continue on that front, and beyond that, we are also exploring other facilities and other avenues to continue to repatriate cash from China. So those are, I think, some of the elements that we're continuously evaluating to bring bad money back.

Speaker Change: Yes.

Speaker Change: With regards to your second question this is Juan.

Juan: With regards to the cash in China cash generation in China.

Juan: Over the course of the last year or so.

Speaker Change: We have been repeating repatriating cash from China based on a facility that we had setup as registered debt with.

Speaker Change: With our China operations, we will continue on that front.

Speaker Change: And beyond that we were also exploring other facilities other avenues to continue to repatriate cash from China. So those are I think are some of the elements that we're considering reevaluating to bring in and bring back money back to the U S.

Speaker Change: Great. Thank you.

Operator: The next question comes from Jason Gerberry with Bank of America. Please go ahead.

Jason <unk>: The next question comes from Jason <unk> with Bank of America. Please go ahead.

Dina Ramadane: Hi, yes, this is Dina Ramadane on behalf of Jason Gerberry. I just had two questions from us. The first is just, I guess, on sort of an expected timeline of how soon you could look to partner your two preclinical candidates. You know, how early could you begin to have those discussions? Is it kind of fair to assume that you'd look to generate some phase one data beforehand, or would that be on the back of more of like preclinical data? And I have one follow-up question.

Dana <unk>: Hi, Yes. This is Dana <unk> on for Jason Scarberry.

Dana: Q2 questions from that first and just I guess on totally unexpected timeline of how soon you could look to partner or two preclinical candidates.

Dana <unk>: You know how how early could you begin to have.

Speaker Change: Those discussions as it kind of fair to assume that you'd look to generate some phase one data on beforehand or would that be on the back of more of like a preclinical data and then I have one follow up.

Thane Wettig: Thanks, Dina, for the question. So, the data package that we would have to showcase to potential interested parties will be a preclinical data set. Clearly, for the antigolectin-9 antibody, there's a very extensive data set because of the fact that we recently had the IND cleared. And so, we believe there's sufficient information there for potential partners to be able to make the determination of what the path forward could mean and the potential value to them.

Speaker Change: Thanks, Dana for the question.

Speaker Change: So.

Speaker Change: The data package that we would have to showcase to potential interested parties will be a preclinical dataset clearly for the anti collected nine antibody. It's a very extensive data set because of the fact that we had recently had the IND cleared.

Speaker Change: And so we believe there is sufficient information there.

Speaker Change: Or central partners to be able to make the determination of what the path forward could mean in the potential value to them for CRA. We had previously stated that we expected to file an IND sometime in the 2025 timeframe and so we've done as I've said in the opening comments, we've done quite a lot.

Thane Wettig: The CCR8, you know; we had previously stated that we expected to file an IND sometime in the 2025 timeframe. And so, you know, as I've said in the opening comments, we've done quite a lot of work on affinity, maturation, specificity, potency, and feel like, as we compare our antibody to other antibodies, other CCR8, as best we can compare them, you know, in SAR comparisons and things of that nature, we feel very, very good about the optimization work that our team has done on the CCR8 antibody. And so, that would be information that a potential partner would have access to as well. And just to maybe reiterate, you know, there's really a couple of different dynamics in play with these two particular targets.

Speaker Change: Work on.

Speaker Change: Affinity maturation specificity and potency and feel like as we compare our antibody to other antibodies other CRH.

Speaker Change: As best we can compare them.

Speaker Change: Our comparisons and things of that nature that we feel very very good about the optimization work that our team has done on the <unk> antibody and so that would be information of potential partner would have access to as well.

Speaker Change: And just to maybe reiterate.

Speaker Change: There's really a couple of different dynamics in play with with these two particular targets.

Thane Wettig: There's only one other anti-Gal-9 antibody in the clinic, and that's from Gallup Oncology, which is a PureTech spin-off. And so we think we're in a really good position from a timing perspective with our Gal-9 antibody. And then with the CCR8 category, while we aren't in as favorable of a competitive position, it is an incredibly hot space right now, as I'm sure you're aware. There's a lot of activity, and it seems like there's emerging excitement about the mechanism as well. So, you know, we feel good about the ability to partner both of these assets, and we're going to start those activities immediately.

Speaker Change: There is only one other anti <unk> antibody in the clinic and Thats from Gallup oncology, which is a pure tech spin off.

Dina Ramadane: Got it. Thank you.

Speaker Change: So we think we're in a really good position from a timing perspective, with our galvan antibody and then with the CRE category, while we arent as favorable of a competitive position. It is an incredibly hot space right now as Im sure Youre aware theres a lot of activity and it seems like there is theres emerging excitement about the met.

Speaker Change: <unk> as well so we feel we feel good about the ability to partner both of these assets and we're going to start those.

Speaker Change: Activities immediately.

Speaker Change: Got it. Thank you and then one one more follow up for me here just what is I guess, what's the nature of the update we can expect.

Dina Ramadane: And then one more follow-up from me here. Just what is the nature of the update we can expect from the top line data of FG3246's combo trial with Enzulisamide, just in terms of the number of patients and duration of follow-up that we could expect to see? And then wondering if you could please maybe set a bar that you would consider clinically meaningful on the PFS benefit that you'd like to see, sort of confirm the durability of response that we saw at the prior data cut. Thank you.

Speaker Change: From the topline data at June 32, 46, as combo trials with <unk>.

Speaker Change: And knew Angela Tonight I'm, just in terms of patient number of patients and duration of follow up that we could expect expect to see.

Speaker Change: And then wondering if you could please maybe set.

Speaker Change: The bar that you would consider it.

Speaker Change: Clinical clinically meaningful on it on the PFS benefit that you'd like to see sort of confirm the durability of response that we saw at that at the prior data cut thank you.

Thane Wettig: Now that's a really good question, Dean. I'll turn it over to Deyaa to answer that one, and then I'll follow up if needed. Deyaa, do you want to take that one? Sure. Thank you, Thane.

Speaker Change: Now that's a really good question Dean I'll turn it over to David to answer that one and then I'll follow up if needed.

Speaker Change: Ellen.

Deyaa Adib: Sure. Thank you, Thane, and thank you, Dina, for this question. So, the combination study at UCSF, as you have seen at ASCO, has already completed the Phase I dose escalation, and they have already started the Phase II expansion component after realizing the recommended Phase II dose. So having said that, the data that you have seen from those escalation is very, very encouraging because of the fact that the majority of those 17 patients were both two prior ARS patients.

David: Sure. Thank you Dan and thank you Dina afford this question. So the combination study at UCSF.

Speaker Change: As you have seen us at school has already completed the phase one dose escalation and they have already started.

Speaker Change: Phase two.

Speaker Change: Expansion component after realizing the.

Speaker Change: The recommended phase II dose.

Speaker Change: So having said that the data is that you have seen from.

Speaker Change: From dose escalation is very very encouraging.

Speaker Change: Because of the fact that the majority of those 17 patients.

Speaker Change: Where post two prior aortic size this.

Deyaa Adib: This population is. They have also failed abiraterone acetate. They then constitute this area of medical need. So for those patients to have 10.2 months of radiographic PFS, this is very exciting. The bar for this setting, meaning after patients have failed two prior ARSIs, is around six months of RPFS. So as you can see, the combo has already exceeded that.

Speaker Change: Population is.

Speaker Change: They have also failed abiraterone.

Speaker Change: Hey.

Speaker Change: They've done constitute this area.

Speaker Change: Medical need so for those patients to have $10 two months, so that geographic PFS. This is very exciting.

Speaker Change: The bar for this setting meaning after patients have failed to probably a payout of size is around six months at a PFS.

Speaker Change: As you can see Docomo has already exceeded.

Deyaa Adib: The current bar, which is only six months, in terms of moving up the treatment line once they come. With more patients in the second-line setting, meaning patients who have completed only one prior ARSI, we are going to see potentially much higher RPFS. And in this case, the comparison will be somewhere between 18 to 20.

Speaker Change: The current bar, which is only six months.

Speaker Change: In terms of moving up the treatment line once the clock.

Speaker Change: Okay.

Speaker Change: <unk> patients in the second line setting, meaning patients who have completed only one probably on the aortic side.

Speaker Change: We are going to see potentially much higher.

Speaker Change: ATA PFS and in this case, the comparison will be somewhere between 18% to 20 months. This is the current bar with abiraterone acetate and in <unk> in the food.

Deyaa Adib: This is the current bar with abiraterone acetate and enzalutamide in the first, strictly first line. So this is the current landscape, and we are hoping that in Q1 of, or I mean the first half of next year, we will be able to publish the top line results from the combination, having a total of 36 patients in the study. So it will be a robust data set to give us a meaningful signal of clinical activity in either line, second line, or first line.

Speaker Change: The first line setting.

Speaker Change: So.

Speaker Change: This is the current landscape.

Speaker Change: And we are hoping that in the Q1 or I mean first half of next year, we will be able to publish the topline results from the combination.

Speaker Change: Having a total of 36 patients in the study.

Speaker Change: Well it will be a robust data set to give us a meaningful signal of clinical activity in either line second line or first line centric.

Thane Wettig: Thanks Deyaa, that was excellent. Dina, one thing that I would add is that these additional patients that are being enrolled now as part of the expansion cohort will also have PET imaging data as well. So that's in addition to a more mature RPFS that Deyaa spoke of, we'll also begin to see some information and be able to characterize CD46 expression and potential response as well. Small numbers, but it will be an important additional data point for us.

Speaker Change: Thanks, Dave that was that was excellent.

Speaker Change: One thing that I would add is that these additional patients that are being enrolled Dallas part of the expansion cohorts will also have pet imaging data.

Speaker Change: Data as well so that's an addition to our more mature PFS data spoke to will also begin to see some information and be able to characterize CD 46 expression and potential response as well.

Speaker Change: All numbers, but it will be.

Speaker Change: An important additional data point for us.

Dina Ramadane: I appreciate all the color. Thank you so much.

Speaker Change: I appreciate all the color. Thank you so much.

Speaker Change: Okay.

Operator: The next question comes from Paul Choi with Goldman Sachs. Please go ahead.

Speaker Change: The next question comes from Paul Choi with Goldman Sachs. Please go ahead.

Paul Choi: Hi, good afternoon, and thank you for taking our questions. My first question is on the updated guidance, and can you maybe comment on how much of this may be driven by a potential raise in guidance, may be driven by potential approval of a CIA indication versus continued volume growth from the CKD indication? And then my second question is, I believe in July a generic version of Roxodus was approved. I'm curious if you are starting to see it in the marketplace there yet, and just what your thoughts are on the pricing impact.

Paul Choi: Hi, good afternoon, and thank you for taking our questions. My first question is on the updated guidance can you maybe comment on how much of this maybe driven by a potential.

Paul Choi: Raise guidance, maybe driven by potential approval of a ci indication versus continued volume growth from the CK D indication.

Speaker Change: And then my second question is I believe in July a generic Rockford us that was approved.

Speaker Change: Curious if you are starting to see it in the marketplace there yet.

Speaker Change: Just what your thoughts are on the pricing impact I think you had about a 12% headwind from pricing on your volume offsetting your volume this quarter any updated thoughts on the pricing impact from the competitive launch would be appreciated.

Paul Choi: I think you had about a 12% headwind from pricing on your volume, offsetting your volume this quarter. So any updated thoughts on the pricing impact from the competitive launch would be appreciated. Yeah, thanks, Paul. It's Thane. I'll go ahead and start, and then I'm going to turn it over to Chris as well.

Thane Wettig: Yeah, thanks, Paul. It's Thane. I'll go ahead and start, and then I'm going to turn it over to Chris as well.

Speaker Change: Yes, Thanks, Paul I'll go heads.

Speaker Change: And then I'm going to turn it over to Chris as well.

Thane Wettig: In terms of the underlying performance of Rox2Stat in China and the radius of the guidance, it's 100% due to continued strong performance by the team in the anemia CKD indication and that indication by itself. There's no, you know, pre-ordering and anticipation of CIA approval or anything like that. So, it's all just inherent, strong, underlying demand. In terms of generic entry, as we said in our opening remarks, there have been two generics that are approved.

Thane Wettig: In terms of the underlying performance of rock...

Chris: In terms of the underlying.

Speaker Change: Performance of <unk> in China.

Speaker Change: And in the raise of the guidance, it's 100% due to continued strong performance by the team in the <unk> indication.

Chris: And that indication by itself there is no pre ordering in anticipation of the CIA approval or anything like that so it's all just inherent strong underlying demand.

Speaker Change: In terms of the.

Speaker Change: The generic <unk>.

Speaker Change: Entrants as we said in our opening remarks, there have been two generics that are approved.

Thane Wettig: You know, this walked out from 33% volume growth to 31% to 21% revenue growth. There was a 7% price reduction as part of the VPP renewal at the end of last year, and so there's not a 12% price headwind. There was a 7% price headwind. And then, you know, the expected pricing will really be dependent upon what happens if and when the government calls for VVP, and for Rox2Stat to be included in VVP. Let me ask Chris to add some additional color, given her intimate knowledge of the environment there. Yeah, thank you.

Speaker Change: No.

Speaker Change: This walk down from 33% volume growth to 31% to 21% revenue growth there was a 7% price reduction as part of the BBB and renewal at the end of last year.

Speaker Change: And so theres not theres, not a 12% price headwind there was a 7% price headwind.

Speaker Change: And then.

Speaker Change: The expected pricing will really be dependent upon what happens if and when the government calls for <unk>.

Chris: <unk> set to be included in Pvp, Let me ask Chris to add some additional color on given her intimate knowledge of the environment there.

Chris: Yes, Thank you team so Paul.

Speaker Change: We have not seen the launch.

Speaker Change: Like generic on the market is very difficult to give me a sense of market adoption.

Speaker Change: With respect to pricing at this point in time I have no plans to change pricing in response to generic entry.

Speaker Change: We are subject.

Speaker Change: Yes.

Chris: Okay, great. And if I could squeeze in one pipeline question, please, just on 3246, to follow up on the combination data. I guess, as you think about planning, that, obviously, you'll work on the dose optimization starting next year. But as you look.

Speaker Change: Okay, great and if I could squeeze in one pipeline question. Please just on Thursday of 46.

Speaker Change: To follow up on the on the combination data.

Speaker Change: Yes.

Speaker Change: Think about planning that.

Speaker Change: You work on the dose optimization, starting starting next year, but as you've looked look down the road.

Speaker Change: Is there any particular.

Speaker Change: Ill population beyond.

Speaker Change: The positive that you think might be additionally, benefiting from the combination or will your primary focus in terms of like increasing the probability of success be focused primarily on the pet positive population.

Paul Choi: Yeah, so I'll start off and then Deyaea, I'm going to turn it over to you. Sure. So really, what we're going to be...

Speaker Change: Yeah, So I'll start off and then.

Shaun: I'll turn it over to you Shaun so really what we're going to be what we're going to be exploring in the phase II. Paul is with a pet is trying to understand if there is a correlation between CD 46 expression and response to the drug that could then allow us to enrich the phase III portion of the trial.

Shaun: So we're not using it as any sort of a.

Speaker Change: A diagnostic or patient selection criteria as part of the phase two we are using it to understand that there is a correlation and if there is then that would really enable us to enrich the phase III portion of the trial.

Shaun: Dale will go ahead and add to that and then Paul will see that addressed your question.

Deyaa Adib: Yeah, Paul. So thank you for the question. I completely, you know, confirm what Thane has just mentioned. But on top of that, remember that data derived from our phase one study. This was conducted in four tests. In addition to the current combination, QTSF with enzalutamide has all been conducted in an unselected population.

Paul Choi: Yeah, Paul So thank you for the question.

Paul Choi: <unk> completely confirmed.

Speaker Change: <unk> has just mentioned, but on top of that remember that data derived from our phase one study.

Speaker Change: By fourth this.

Speaker Change: In addition to the current combined nation.

Speaker Change: CSF within Zillow combined has all been conducted in an unselected population.

Deyaa Adib: So that is very true. Our primary focus will be to enhance the opportunity for patients to derive clinical benefit by pre-selecting them with PET-46. But when we talk to our KOLs, they also tell us that there could be another opportunity for all comers if the data continue to show robustness and a strong signal of RPF. So this is not something that we will abandon, but it is going to be another opportunity for all comers as long as we continue to see very strong growth. But the primary focus will be PEPFORI 6-2.

Speaker Change: So that is very true our our primary focus will be to enhance the opportunity for patients to derive clinical benefit by pre selecting them at 46, but when we talk to our Kols. They also tell us that there could be another opportunity in all comers if the data continue to.

Operator: Okay, got it. Thank you very much. And guys, we still have a few more minutes. Adal and Dina, Paul, if you have any additional questions.

Speaker Change: Sure robustness and strong signal of our PFS.

Speaker Change: So this is like not a.

Speaker Change: Something that we will abandon but it is going to be another opportunity.

Speaker Change: In all comers as long as we continue to see very strong data.

Speaker Change: But the primary focus will be pet 46 pre selection.

Speaker Change: Okay got it thank you very much.

Speaker Change: Alright, guys, we still have a few more minutes adult Indiana, Paul if you have any additional questions.

Thane Wettig: There appear to be no further questions in the queue, so this will conclude our question and answer session. I would like to turn the conference back over to Thane Wettig for any closing remarks.

Speaker Change: Peter will be no further questions in the queue. So this will conclude our question and answer session I would like to turn the conference back over to <unk> for any closing remarks.

Thane Wettig: Thank you, and we really appreciate your participation in today's call and your interest in FibroGen. Enjoy the rest of your day. Thanks, guys.

Speaker Change: No. Thank you and we really appreciate your participation in today's call and your interest in fiber just enjoy the rest of your day. Thanks guys.

Operator: The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.

Speaker Change: Thank you.

Speaker Change: The conference has now concluded. Thank you for attending today's presentation you may now disconnect.

Speaker Change: [music].

Speaker Change: Yeah.

Speaker Change: